Invivo 3GSPO2 Wireless SpO2 for Patient Monitoring in MRI Environments User Manual 989803193211
Invivo Corporation Wireless SpO2 for Patient Monitoring in MRI Environments 989803193211
Invivo >
Manual
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| Document ID | 2577538 |
| Application ID | ksZo7Jp6xeddN1uHuKrW/g== |
| Document Description | Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 436.07kB (5450834 bits) |
| Date Submitted | 2015-04-08 00:00:00 |
| Date Available | 2015-10-05 00:00:00 |
| Creation Date | 2015-02-11 09:31:31 |
| Producing Software | Acrobat Distiller 10.1.12 (Windows) |
| Document Lastmod | 2015-03-11 08:59:19 |
| Document Title | 989803193211.book |
| Document Creator | FrameMaker 12.0.2 |
| Document Author: | usd29806 |
Expression MR400 MRI Patient Monitoring System INSTRUCTIONS FOR USE Revision A English *989803193211* 989803193211 Manufacturer Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826, USA 877‐468‐4861 E‐mail: Info@invivocorp.com Websites: www.ExpressionMR.com www.invivocorp.com www.philips.com Identification and Publication Details Published by Invivo, a division of Philips Medical Systems. Invivo, a division of Philips Medical Systems, reserves the right to make changes to both this Instructions for Use and to the product it describes. Product specifications are subject to change without notice. Nothing contained within this Instructions for Use is intended as any offer, warranty, promise or contractual condition, and must not be taken as such. © Koninklijke Philips N.V. (Royal Philips) 2015 All rights reserved. Reproduction in whole or in part in any form or by any means, electrical, mechanical or otherwise is prohibited without the written consent of the copyright holder. REF 989803193211 Rev. A, March 2015 Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826 USA Unauthorized copying of this publication may not only infringe copyright, but also reduce the ability of Philips Medical Systems to provide accurate and up‐to‐date information to users. Published in USA ii Regulatory Compliance The Expression MR400 MRI Patient Monitoring System complies with relevant international and national standards and laws. Information on compliance will be supplied on request by your local Royal Philips representative, or by the manufacturer. Explanation of Symbols The symbols in the following table may appear on the Expression MR400 MRI Patient Monitoring System, the accessories, or the packing material. Symbol Symbol Underwriters Laboratories Component Recognition Mark for both the U.S. and Canadian markets Federal Communications Commission radio certification Ministry of Internal Affairs and Communications Japanese Radio Law Certification UL has determined that the product meets requirements Korean Communications Commission radio certification Taiwan National Communications Commission certification Conforms to the European Medical Devices Directive Conforms to the R&TTE Directive (Radio & Telecommunications Terminal Equipment) Authorized representative in the European Community Serial number Catalog, reorder or reference part number Batch code / lot number iii Symbol iv Symbol Sterilized using radiation Unique device identifier Sterilized using ethylene oxide In vitro diagnostics compliant MR Conditional: Use in the MR environment is restricted to certain conditions of use to ensure patient and operator safety. MR unsafe: Must not be used in an MRI environment MR safe: Completely safe for use with no potential for interaction with the MR field. Warning! Specific warnings associated with the devices that are not otherwise found on the label; and, on the connector of the wireless ECG patient module, this indicates that only specified ECG lead cables shall be used to ensure safe use in the MR and defibrillation protection. Consult the Instructions for Use Caution! See Instructions for Use for specific warnings or precautions associated with the devices that are not otherwise found on the label The Instructions for Use must be consulted Separate to open then insert Do not adjust without referring to the service manual Single use only, disposable one-time-use product; do not reuse Do not use if container is damaged Defibrillator-proof type CF equipment (IEC 606011) protection against shock Symbol YYYY-MM-DD YYYY-MM Symbol Use by date; do not use after the year (YYYY), month (MM) and day (DD) indicated Cable tag marked with use by date; do not use after the year (YYYY) and month (MM) indicated Use by date; do not use after the year (YYYY), month (MM) AC receptacle, below Do not push Correct Alternating current Not sterile SPO2 probe quantity equals Direct current Adult SPO2 clip quantity equals Pediatric SPO2 clip quantity equals Infant SPO2 grip quantity equals Neonatal SPO2 grip quantity equals Adult SPO2 grip quantity equals Pediatric SPO2 grip quantity equals Infant Neonate Toe site Thumb site Finger site Big toe site Symbol vi Symbol Prescription only Foot site NIBP cuff, correct side out Temperature range Non-pyrogenic fluid path NIBP cuff, wrong side out Airway adapter quantity equals NIBP cuff circumference range Anesthetic oxygen (O2) sensor location and part number IBP transducer cable quantity equals Weight Cannula quantity equals Humidity range Humidity range, non condensing For indoor use only Equipotential (earth) ground Fragile Keep dry Symbol Symbol Keep away from heat Atmospheric pressure limitation Packages per box Up Quantity equals Non-invasive blood pressure (NIBP) connection Not manufactured with natural latex rubber Quadtrode electrode Contains or presence of phthalate: bis (2ethylhexyl) phthalate Quadtrode electrode per package Non-ionizing radiation ECG AAMI ECG CV lead cable connections AAMI ECG lead cable connections AAMI ECG NEO lead cable connections IEC ECG CV lead cable connections IEC ECG lead cable connections IEC ECG NEO lead cable connections vii Symbol viii Symbol Cardiac gating output Universal Serial Bus (USB) Conforms to the RoHS directive Not for general waste Center positive connection: Positive (+) center pin, negative (-) outer ring Pneumatic respiration connection Gas input indicator Gas output indicator Electrical input indicator Electrical output indicator Temperature connection Electrostatic discharge (ESD) warning Manufacturer name and address Date of manufacture (year-month) YYYY-MM Non-magnetic part Battery Main battery (left side) Main battery (right side) Symbol Symbol Do not move the Expression MR400 MRI Patient Monitoring System inside the 5000 gauss field line of the MR magnet or up to the face of a 3T magnet, whichever is greater, as measured from the center line of the bore. Apply wheel locks and do not move the Expression MR400 MRI Patient Monitoring System inside the 5000 gauss field line of the MR magnet or up to the face of a 3T magnet, whichever is greater, as measured from the center line of the bore. Charge indicator, cart battery Wheel lock Power level button, cart battery MRI compatible, up to 2500 gauss Setup key Main Screen key Zero All key Print key, printer ready indication Clear Trends key Print key, printing in process (and time remaining) indication NIBP Interval key Print key, no printer available indication 1-Touch Alarms key Print key, printer error indication Suspend key Trends key NIBP Start/Stop key ECG Filter key Connected to AC mains Audio Pause key Alarm audio armed Alarm key ix Symbol Symbol Alarm audio paused After opening, allow at least 1 hour to pass before use Alarm audio off Current setups have changed Power switch (Standby switch) Heartbeat detected Module battery adequate charge indication Breathing effort detected Module battery low charge indication Battery 1 indicator, wireless ECG patient module, Battery 2 indicator, wireless ECG patient module, Battery indicator, wireless SpO2 patient module No communication IP5 connected Network channel 1 Network channel 6 Network channel 2 Network channel 7 Network channel 3 Network channel 8 Network channel 4 Network channel 9 Symbol Symbol Network channel 5 Network channel 10 Ten FlexTEMP System Jackets per box Conventions Certain conventions are used throughout the Expression MR400 MRI Patient Monitoring System to speed use and familiarity with the device. This accompanying user information also uses document conventions to assist you in finding and understanding information. System Conventions The following system conventions are used: • Operational control is accomplished using the touch screen, where active elements are provided and touching that element will activate, open or execute the related menu, function or item. • Most menus employ a time‐out feature where, if no action is taken for approximately 30– 60 seconds, an open menu will automatically close. • To protect against accidental changes, a dialog prompt is associated with some menu options. When displayed, you must answer this prompt; otherwise, a delay of approximately 30–60 seconds will be equivalent to selecting No (this can also be accomplished by pressing the Main Screen key.) • To protect against unauthorized changes, some menu items feature password protection. You must enter the correct numeric code for access and a delay of approximately 30–60 seconds is equivalent to making no entry. Document Conventions These document conventions are used: xi • All procedures are numbered and any sub‐steps are lettered. Complete the steps in the sequence presented to ensure success. Procedures are indicated by the following table: Step Action xii • Unless noted, all procedures start from the normal mode of operation. • Select means to press on an active element on the touch screen LCD (menu or sub‐menu item, button, key, vital sign box, et cetera). • Bulleted lists indicate general information about a particular feature, menu function or procedure, and do not imply sequential order or operation. • Control names, menu items, vital sign references, messages, et cetera, are spelled as they appear on the Expression MR400 MRI Patient Monitoring System. • Menu items, key names and messages are provided in bold font. • The “greater than” (>) symbol is used when navigation of items within a menu is indicated. • The front of the Expression MR400 MRI Patient Monitoring System is nearest you as you operate it; the left and right sides are respectively to your left and right as you stand in front of the system, facing it. • The front of a wireless module is nearest you as you operate it. The top of the device points up or away when the labeling nearest you during operation is correctly oriented for reading, while the left and right sides of the device are respectively to your left and right as you hold the device for operation, facing it. Contents Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Identification and Publication Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iii Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iii Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-xi System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-xi Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-xi Chapter 1: Important Information About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Contra-indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Equipment Classification (According to IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 Radios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8 Using Batteries Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 Examining the Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 Disposing of the Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14 Initial Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14 Installing and Connecting Cart Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16 Attaching the SpO2 Probe to the wSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18 Rear Panel Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19 Connecting AC Mains Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20 Understanding Battery Operations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21 Cart Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21 Charging Cart Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21 Removing Cart Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22 Wireless Module Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23 Charging Module Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24 Installing Batteries in the wECG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24 Removing Batteries from the wECG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25 Installing a Battery in the wSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26 Removing the Battery from the wSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27 Understanding Wireless Network Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27 Setting the Wireless Network Channel of the Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27 Setting the Wireless Network Channel of the wECG and wSpO2 Modules . . . . . . . . . . . . . .1-29 Advanced User Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Expression Information Portal (Model IP5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-33 Additional Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-33 Accessory List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Chapter 2: System Overview System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Contents 1 System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Use Model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acquisition and Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Synchronization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Device Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 2-3 2-3 2-4 Hardware Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Patient Connection Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 wECG and wSpO2 Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8 wECG Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 wECG Module Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 wSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11 wSpO2 Module Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11 Storing Modules and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Displayed Information and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 Information Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Soft Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Status Information Pane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Status Information Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vital Sign Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No Data Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other Data Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vital Sign Traces and System Message Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 2-15 2-16 2-18 2-19 2-20 2-21 2-21 Navigation and Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22 Specialized Control Buttons and Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Default Setting Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Password Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22 2-23 2-23 2-23 Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23 Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23 Suspend Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24 Simulation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24 Chapter 3: Getting Started Defibrillator and Electrosurgical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Positioning the MR400. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Operating the MR400. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 System Power-up and Communications Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Cart Power-down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Wireless Module Power-down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Monitor Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Viewing the Displayed Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Default Setting Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 User Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 Initial Alarm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 Selecting the Patient Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 Setup Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13 2 Contents Monitor Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14 Edit User Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15 Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18 Sound Adjust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20 Set Time & Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22 Sweep Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25 Resp Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25 Service(Bio-Med) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26 Revision Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28 Simulation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29 Gas Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30 System Config . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30 ECG Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-32 NIBP Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33 Backlight Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-34 Service Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-35 Chapter 4: Alarms Alarm Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Visual Alarm Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Alarm Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2 Flashing Numeric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3 Alarm Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3 Audible Alarm Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Alarm Sound State Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4 Initial Audible Alarm Setting Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5 Controlling the Alarm Audio and Light Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5 Audio Pause Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6 Audio Off Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6 Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7 Alarm Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7 Managing Alarm Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Showing or Hiding Current Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8 Adjusting the Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9 Alarm Limit Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9 The Alarm Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11 Advanced Alarm Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11 Setting Alarm Limits Globally. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12 Setting Alarm Limits Individually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13 Restoring Alarm Limit Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16 Enabling Print on Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17 Alarms Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17 1-Touch High % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18 1-Touch Low % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19 Alarm Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20 Alarm Light. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20 Default Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21 Limits Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21 Adjustable Alarm Limit Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22 Contents 3 Alarm Limit Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24 Measurement Limits and Over / Under Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25 Listing of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26 Patient and INOP Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Technical (INOP) Alarms and Other Status Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SPO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CO2 / CO (RESP) / AGENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P1 (or P2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NIBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other Status Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27 4-31 4-31 4-32 4-33 4-35 4-36 4-36 4-37 Chapter 5: Monitoring ECG ECG Monitoring Considerations for the MR Environment . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 wECG Module and ECG Lead Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Quadtrode Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Work Flow for ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Selecting the ECG Lead Cable and Quadtrode Electrode Type. . . . . . . . . . . . . . . . . . . . . . . 5-5 Identifying the Placement Site for the Quadtrode Electrode . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7 Preparing the Quadtrode Electrode Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 Attaching the ECG Lead Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12 Lead Fail Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15 Checking the ECG Signal Strength. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 Selecting the Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 Changing the Lead View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17 Minimizing ECG Waveform Noise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 Positioning the ECG Lead Cable and wECG Module for Scanning . . . . . . . . . . . . . . . . . . . 5-19 Selecting the Filter Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22 ECG Waveforms and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22 Changing the Heart Rate Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24 ECG Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26 Trace A Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Trace B Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Gating Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HR Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HR Tone Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Filter Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Extreme HR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pediatric ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . T-Wave Suppression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27 5-28 5-28 5-29 5-29 5-30 5-31 5-32 5-32 5-33 Chapter 6: Monitoring SPO2 wSpO2 Module, SpO2 Probe and SpO2 Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Patient Preparation for SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Selecting the Site and SpO2 Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Attaching the Clip or Grip to the SpO2 Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 4 Contents Applying the SpO2 Attachment to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3 Perfusion Index Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6 Positioning the wSpO2 Module for Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6 SPO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8 Assessing Suspicious SPO2 Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9 Changing the SPO2 Waveform Amplitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10 Changing the SPO2 Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11 SPO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12 Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13 Averaging Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14 Perfusion Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15 Gating Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15 Desat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15 Desat Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16 HR Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-17 HR Tone Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-18 Chapter 7: Monitoring CO2 (LoFlo Option) MR400 Preparation for CO2 Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Operation and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Warm-Up Period. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2 Zero Reference Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2 Breath Rate Distortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3 Patient Preparation for CO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Selecting the CO2 Accessory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4 Connecting the Sampling Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4 Applying the Sampling Line to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6 CO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Changing the CO2 and CO2 (RESP) Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9 Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-11 CO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12 Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13 Grids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14 Zero Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15 Chapter 8: Monitoring Invasive Blood Pressure Indications and Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Adult and Pediatric Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 Neonatal Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 Patient Preparation for IBP Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Transducer Component, Connection, and Feature Locations . . . . . . . . . . . . . . . . . . . . . . 8-2 MR 400 Preparation for IBP Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Adult and Pediatric Patients: Expression MR IBP DPT Kit, A/P (REF 989803194631) . . . . . .8-4 I. Connecting the Reusable Cable to the MR400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4 II. Kit Set Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5 III. Purging Air from the Monitoring Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6 IV. Zeroing, Leveling and Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-7 V. Connecting the Monitoring Kit to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8 Contents 5 The IBP transducer must not be mounted to the patient, or patient burn may result. . . 8-8 VI. Fast Flushing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9 VII. Checking for Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9 VIII. In the MR Room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9 Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641). . . . . . . . . . . . . 8-10 I. Connecting the Reusable Cable to the MR400. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10 II. Kit Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10 III. Purging Air from the Monitoring Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12 IV. Zeroing, Leveling and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12 V. Connecting the Monitoring Kit to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14 VI. Checking for Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15 VII. In the MR Room. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15 Zeroing the Pressure Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16 Systolic/Diastolic Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mean Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the P1 (or P2) Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the P1 (or P2) Waveform Amplitude. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the P1 (or P2) Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17 8-18 8-19 8-19 8-20 8-22 P1 (and P2) Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-22 Zero Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Set Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HR Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Grids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Grids Size. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-24 8-24 8-25 8-26 8-26 8-27 8-28 Chapter 9: Monitoring Agents and Gases (AGENT Option) MR400 Preparation for AGENT Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 Operation and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 Warm-Up Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 Zero Reference Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 Breath Rate Distortion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3 CO2 Low Flow and Occlusion Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4 Selecting AGENT Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5 AGENT Tubing Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5 Pre-Use System Checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8 Applying the Sampling Line to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10 Water Trap Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13 AGENT and GAS VS Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14 Multiple (Mixed) Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AGENT VS Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GAS VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the AGENT and GAS Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15 9-16 9-17 9-17 MAC Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20 CO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22 Changing the CO2 and CO2 (RESP) Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23 Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-26 6 Contents CO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27 Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-28 Grids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-29 Zero Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-30 Chapter 10: Monitoring RESP Patient Preparation for RESP Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 Monitoring Respiration using CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1 Monitoring Respiration using the Bellows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1 Bellows Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2 Respiration VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 Changing the CO2 (RESP) Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5 RESP Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5 Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7 Apnea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8 Apnea Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8 Chapter 11: Monitoring Temperature General Usage Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 Initial Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2 Connecting and Disconnecting the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 Temperature Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 Making Surface Temperature Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4 Making Body Temperature Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5 Placing the Temperature Sensor in a Jacket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5 Placing the Temperature Sensor at the Body Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6 Post-Measurement Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7 Accuracy Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8 TEMP VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8 Changing the TEMP Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-9 Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-10 TEMP Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10 Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-11 Chapter 12: Monitoring NIBP Patient Preparation for NIBP Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2 Selecting the NIBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-3 Positioning the NIBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-5 Connecting the NIBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5 Choosing the Measurement Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-6 Making Automatic Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-6 Making Manual Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7 Initial Inflation Pressures and Reading Durations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7 Stopping an NIBP Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-8 Suspend Mode during NIBP Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-8 NIBP VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8 Systolic/Diastolic Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-8 Contents 7 Mean Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the NIBP Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the NIBP Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10 12-11 12-11 12-12 NIBP Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14 Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15 Auto Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-16 Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17 Chapter 1:3 Trend Data and Printing Trending Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1 Viewing Tabular Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tabular Trends Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Trend Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Arrow Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Data Interval. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clear Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Print Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Print All. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Stop Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1 13-1 13-4 13-6 13-7 13-8 13-9 13-9 13-9 Printing Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10 Printing Parameter-Specific Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10 Controlling Printer Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10 Printer Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11 Printer Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11 Trace 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13 Trace 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14 Trace Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15 Chapter 14: Maintenance and Troubleshooting General Cleaning Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1 Removing all Power to the MR400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2 Restoring all Power to the MR400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4 Removing Power from the Wireless Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4 Restoring Power to the Wireless Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4 User Routine-Checks and Planned Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4 Cleaning, Disinfection, and Damage Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-6 Cleaning, Disinfecting, and Inspecting the Accessories. . . . . . . . . . . . . . . . . . . . . . . . 14-7 Cleaning, Disinfecting, and Inspecting MR400 and Wireless Modules . . . . . . . . . . . . 14-9 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-10 Testing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-11 Testing a Dropped Wireless Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-12 Verification Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-13 Anesthetic Oxygen (O2) Sensor Depletion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-13 Replacing the O2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-13 Updating Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15 Calibrating the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16 8 Contents Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-17 Passing the Product on to another User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-18 Packaging the MR400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-18 Final Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-21 Disposal of the MR400 and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-21 Fitting, Removing and Disposing of Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-22 Appendix A: Specifications General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 Displayed Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6 ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7 Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 CO2 (Optional LoFlo) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10 Invasive Blood Pressure (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13 AGENT (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-15 Bellows Respiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23 Temperature (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23 Non-Invasive Blood Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-24 Gating Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-28 Appendix B: Warranty Warranty Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 Appendix C: Regulatory Information European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 Authorized Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 Australia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 Appendix D: Gating Feature MR400 Preparation for Gating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 Gating Connector Pin-outs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 Using the Gating Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2 Using ECG Gating. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2 Using SPO2 Gating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4 Appendix E: Guidelines and References Guidelines for the Prevention of Excessive Heating and Burns Associated with Magnetic Resonance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3 Contents 9 10 Contents CHAPTER 1 Important Information About About the Expression MR400 MRI Patient Monitoring System and this Instructions for Use This Instructions for Use is intended to assist users in the safe and effective operation of the Expression MR400 MRI Patient Monitoring System. Before attempting to operate the product, you must read this Instructions for Use, noting and strictly observing all WARNINGS and CAUTION notices. Pay special attention to all the information given and procedures described in the SAFETY section. A WARNING alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. A CAUTION alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury, and/or cause environmental pollution. A Note highlights an unusual point as an aid to a user. This Instructions for Use describes the most extensive configuration of the product, with the maximum number of options and accessories. Not every function described may be available on your product. This product will perform in conformity with the description contained in this manual and accompanying labeling when operated, maintained and repaired in accordance with the instructions provided. This device must be checked and calibrated periodically. A malfunctioning device must not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated must be replaced immediately. Refer the device to qualified service personnel for repair or replacement. This device or any of its parts must not be repaired other than in accordance with written instructions provided by the manufacturer. The device shall not be altered without written approval of Royal Philips. The user has the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than authorized service personnel. Expression MR400 Instructions for Use Important Information 1‐1 Intended Use This Philips product is intended to be used and operated only in accordance with the safety procedures and operating instructions given in this Instructions for Use for the purposes for which it was designed. The purposes for which the product is intended is given below. However, nothing stated in this Instructions for Use reduces users’ responsibilities for sound clinical judgment and best clinical procedure. The Expression MR400 MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for the synchronization of the MRI scanner. Use and operation of this product is subject to the law in the jurisdiction(s) in which the product is being used. Users must only install, use and operate the product in such ways as do not conflict with applicable laws, or regulations, which have the force of law. Uses of the product for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use or operation, may relieve the manufacturer (or his agent) from all or some responsibility for resultant non‐compliance, damage or injury. CAUTION Federal law restricts this device to sale by or on the order of a physician. Compatibility The product described in this manual should not be used in combination with other products or components unless such other products or components are expressly recognized as compatible by Philips Medical Systems. [A list of such products and components is available from the manufacturer]. Changes and/or additions to the product should only be carried out by Philips Medical Systems or by third parties expressly authorized by Philips Medical Systems to do so. Such changes and/or additions must comply with all applicable laws and regulations that have the force of law within the jurisdiction(s) concerned, and with best engineering practice. WARNING Warning Changes and/or additions to the product that are carried out by persons without the appropriate training and/or using unapproved spare parts may lead to the PMS warranty being voided. As with all complex technical products, maintenance by persons not appropriately qualified and/or using unapproved spare parts carries serious risks of damage to the product and of personal injury. 1‐2 Important Information Expression MR400 Instructions for Use Indications for Use The Expression MR400 MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner (also referred to as “triggering” or “gating”). The Expression MR400 provides monitoring for the following vital signs and parameters: electrocardiogram (ECG), pulse oximetry (SpO2), non‐invasive blood pressure (NIBP); and optionally, invasive blood pressure (IBP), carbon dioxide (CO2) and respiration rate, anesthetic agents, oxygen (O2), nitrous oxide (N2O), and temperature. Notes • The MR400 is intended to be used to monitor the vital signs of a patient in an MR magnet room. Monitoring outside the magnet room (e.g., the MR induction and/or MR recovery areas) is acceptable for the short duration of time in which the patient is being prepared for the MR scan and during the recovery period within the MR. This system is not intended for use on a patient being transported outside of a health care facility. • The MR400 is intended for use on patients receiving MR scans, which may include neonatal, pediatric, or adult patients. If determined by a qualified healthcare provider, this may also include pregnant patients. • The bellows-derived respiration rate measurement is not intended for vital sign monitoring. Contra-indications This Philips product should not be used if any of the following contra‐indications exist or are thought to exist. This device is contra‐indicated for patients with metallic wires, implants, stents, et cetera. Screen all patients for metallic wires, implants, stents, et cetera prior to MR procedures. These electrical conductors will react with the MR environment or with the accessory (if applied directly over the conductor), thus increasing the risk of heating. The warnings below refer to the Expression MR400 MRI Patient Monitoring System in its entirety. WARNINGS • The Expression MR400 MRI Patient Monitoring System is not intended for use with patients using pacemakers or electrical stimulators. • Do not use if MR workers are present who have metallic wires, implants, stents, et cetera. Screen all MR workers for metallic wires, implants, stents, et cetera, prior to MR procedures when using the Expression MR400 MRI Patient Monitoring System in the MR magnet room. • Do not use on patients with metallic wires, implants, stents, et cetera. Screen all patients for metallic wires, implants, stents, et cetera, prior to MR procedures. These electrical conductors will react with the MR environment or with the accessory (if applied directly over the conductor), thus increasing the risk of heating. Expression MR400 Instructions for Use Important Information 1‐3 Training Users of this product must have received adequate training on its safe and effective use before attempting to operate the product described in this Instructions for Use. Training requirements for this type of device will vary from country to country. Users must make sure they receive adequate training in accordance with local laws or regulations. If you require further information about training in the use of this product, please contact your local Philips Medical Systems representative. Alternatively, contact the manufacturer. ADEQUATE TRAINING WARNINGS • Do not use the product for any application until you have received adequate and proper training in its safe and effective operation. If you are unsure of your ability to operate this product safely and effectively DO NOT USE IT. Operation of this product without proper and adequate training could lead to fatal or other serious personal injury. It could also lead to clinical mis-diagnosis or to clinical mistreatment. • Do not operate the product with patients unless you have an adequate understanding of its capabilities and functions. Using this product without such an understanding may compromise its effectiveness and/or reduce the safety of the patient, you and others. Safety Before using the Expression MR400 MRI Patient Monitoring System, read the safety information below. The warnings below refer to the Expression MR400 MRI Patient Monitoring System in its entirety. MAINTENANCE & FAULTS WARNING Warning Do not use the product for any application until you are sure that the user routine-checks have been satisfactorily completed, and that the periodic maintenance of the product is up to date. If any part of the product is known (or suspected) to be defective or wrongly adjusted, DO NOT USE the product until a repair has been made. Operation of the product with defective or wrongly adjusted components could expose the user or the patient to safety hazards. This could lead to fatal or other serious personal injury, or to clinical misdiagnosis, or to clinical mistreatment. 1‐4 Important Information Expression MR400 Instructions for Use SAFETY AWARENESS WARNING Warning Do not use the product for any application until you have read, understood and know all the safety information, safety procedures and emergency procedures contained in this SAFETY section. Operation of the product without a proper awareness of how to use it safely could lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis or to clinical mistreatment. SAFETY DEVICES WARNING Warning Never attempt to remove, modify, or over-ride or frustrate any safety device on the product. Interfering with safety devices could lead to fatal or other serious personal injury. INTENDED USE AND COMPATIBILITY WARNING Warning Do not use the product for any purpose other than those for which it is intended. Do not use the product with any product other than that which Philips Medical Systems recognizes as compatible. Operation of the product for unintended purposes, or with incompatible product, could lead to fatal or other serious injury. It could also lead to clinical misdiagnosis or to clinical mistreatment. ELECTRICAL SAFETY WARNING Warning Do not remove covers or cables from this product (unless expressly instructed to do so in this Instructions for Use). Dangerous electrical voltages are present within this product. Removing covers or cables could lead to serious or fatal personal injury. Covers or cables should [normally] only be removed by qualified and authorized service personnel. Use this product in rooms or areas that comply with all applicable law (or regulations having the force of law) concerning electrical safety for this type of product. Electrically isolate this product from the mains electrical supply before cleaning or disinfecting. Equipotential ground connection: An equipotential ground (earth) connection point is provided. Use this product in areas meeting local standards for electrical safety in rooms used for medical purposes, for example the US National Electrical Code. IEC 60601 also gives guidance about an equipotential ground (earth) connection point. Additional equipotential ground connection: An additional equipotential ground (earth) connection point is provided, because the product is transportable and the reliability of the main equipotential ground connection point might be insufficient. Expression MR400 Instructions for Use Important Information 1‐5 MECHANICAL SAFETY WARNING Warning Do not remove covers from this product unless expressly instructed to do so in this Instructions for Use. Moving parts are present within this product. Removing covers could lead to serious or fatal personal injury. Covers should normally only be removed by qualified and authorized service personnel. In this context, qualified means those legally permitted to work on this type of medical electrical product in the jurisdiction(s) in which the product is being used, and authorized means those authorized by the user of the product. FIRE SAFETY Use of an electrical product in an environment for which it was not designed can lead to fire or explosion. Fire regulations for the type of medical area being used should be fully applied, observed and enforced. Fire extinguishers should be available for both electrical and non‐ electrical fires. WARNING Warning Only use extinguishers on electrical or chemical fires, which are specifically labeled for those purposes. Using water or other liquids on an electrical fire can lead to fatal or other serious personal injury. If it is safe to do so, attempt to isolate the product from electrical and other supplies before attempting to fight a fire. This will reduce the risk of electric shocks. ELECTROSTATIC DISCHARGE Electrostatic discharge (ESD) can amount to a significant voltage, which may cause damage to PCBs or other system components. Caution CAUTIONS • Always wait at least ten seconds after the product is switched OFF before switching the product back to ON. • Always use proper static procedures, protection, and product prior to opening and during handling of this product. This product contains components that are electrostatic sensitive. Failure to use ESD procedures may cause damage to these components. Such damage to components is not covered by Philips warranties. Connections to sensitive parts are identified by the ESD warning symbol (see inset).ESD damage is cumulative and may not be apparent at first, as indicated by a hard failure, but can cause degraded performance. Therefore, always use proper ESD handling procedures. ESD can result from low humidity conditions, use of electrical equipment on carpeting, linens, and clothing. 1‐6 Important Information Expression MR400 Instructions for Use ELECTROMAGNETIC COMPATIBILITY (EMC) This Philips product complies with relevant international and national law and standards on EMC (electromagnetic compatibility) for this type of product when used as intended. Such laws and standards define both the permissible electromagnetic emission levels from product and its required immunity to electromagnetic interference from external sources. Other electronic products exceeding the limits defined in such EMC standards could, under unusual circumstances, affect the operation of the product. • Medical electrical products needs special precautions regarding EMC, and needs to be installed and put into service according to EMC information provided in this Instructions for Use. • The use of accessories and cables other than those specified, may result in increased emission or decreased immunity levels. • The product should not be used adjacent to or stacked with other products and that if adjacent or stacked use is necessary, it should be observed to verify normal operation. CAUTION Portable and Mobile Phones Portable and mobile RF communications can affect medical electrical equipment. Use caution when using such communication devices within the specified range of medical electrical devices. The Expression MR400 MRI Patient Monitoring System may be interfered with by other equipment with CISPR emission requirements. Equipment Classification (According to IEC 60601-1) According to the type of protection against electrical shock: Class I equipment According to the degree of protection against electrical shock: Type CF (defibrillator-proof) equipment According to the degree of ingress protection: Rated IP21: Protected against access to hazardous parts and the ingress of solid foreign objects greater than 12.5mm (0.5 inch); and, protected against vertically dripping liquid. According to the methods of sterilization or disinfection: Non-sterilizable; use of liquid surface disinfectants only According to the mode of operation: Continuous operation Equipment not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. Expression MR400 Instructions for Use Important Information 1‐7 Electromagnetic Compatibility (EMC) The device is intended for use in the electromagnetic environment specified below. Given the device’s electromagnetic emissions and immunity characteristics, the customer or user should assure that the device is used within such an environment. The following information is mandated by IEC 60601‐1‐2, the international standard for the electromagnetic compatibility (EMC) of medical electrical equipment. Radios INDUSTRY CANADA STATEMENT This device complies with Industry Canada license‐exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. FCC COMPLIANCE STATEMENT CAUTION Changes or modifications not expressly approved could void your authority to use this equipment This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Frequency Range: 2402–2482 MHz Modulation Type: GFSK WPU EIRP: 4.2 dBm (peak) wECG and wSpO2 EIRP: 0 dBm (peak) WARNING Warning The use of accessories, transducers and cables other than those specified in the accessory list accompanying this Instructions for Use (with the exception of transducers and cables sold by Invivo (Royal Philips) for the equipment or system as replacement parts for internal components) will result in increased emissions or decreased immunity of the equipment or system. 1‐8 Important Information Expression MR400 Instructions for Use Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below, and the customer or the user should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions, CISPR 11 Group 1 The Expression MR400 MRI Patient Monitoring System uses RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions, CISPR 11 Class B Harmonic Emissions, IEC 61000-3-2 Class B Voltage Fluctuations / Flicker Emissions, IEC 61000-3-3 Complies The Expression MR400 MRI Patient Monitoring System is suitable for use in all establishments, other than domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. Expression MR400 Instructions for Use Important Information 1‐9 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Expression MR400 MRI Patient Monitoring System should assure that it is used in such an environment. Immunity Test Electromagnetic Environment - Guidance IEC 60601 Test Level Compliance Level Electrostatic discharge (ESD) IEC 61000-4-2 ± 6kV contact ± 6kV contact ± 8kV air ± 8kV air Electrical fast transient/burst IEC 61000-4-4 ± 2kV for power supply lines ± 2kV for power supply lines ± 1kV for input/output lines ± 1kV for input/output lines Surge IEC 61000-4-5 ± 1kV differential mode ± 2kV common mode ± 1kV differential mode ± 2kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 < 5% Ut (> 95% dip in Ut) for 0.5 cycle < 5% Ut (> 95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles 70% Ut (30% dip in Ut) for 25 cycles < 5% Ut (> 95% dip in Ut) for 5 seconds < 5% Ut (> 95% dip in Ut) for 5 seconds Mains power quality should be that of a typical commercial or hospital environment. If the user of the Expression MR400 MRI Patient Monitoring System requires continued operation during AC power interruptions, power from an uninterruptible power supply or battery is recommended. 3 A/m 3 A/m Power frequency (50/ 60 Hz) magnetic field IEC 61000-4-8 Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note Ut is the AC mains voltage prior to application of the test level. 1‐10 Important Information Expression MR400 Instructions for Use Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Expression MR400 MRI Patient Monitoring System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Conducted RF IEC 61000-4-6 3 Vrms 150 KHz to 80 MHz V1 = 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz E1 = 3 V/m Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should not be used no closer to any part of the Expression MR400 MRI Patient Monitoring System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = (3.5/V1) d = (3.5/E1) (80 MHz to 800 MHz) d = (7/E1) (800 MHz to 2.5 GHz) Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the symbol. • At 80 MHz and 800 MHz, the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Expression MR400 MRI Patient Monitoring System is used exceeds the applicable RF compliance level above, the Expression MR400 MRI Patient Monitoring System should be observed to ensure normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Expression MR400 MRI Patient Monitoring System. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m. Expression MR400 Instructions for Use Important Information 1‐11 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Expression MR400 MRI Patient Monitoring System The Expression MR400 MRI Patient Monitoring System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Expression MR400 MRI Patient Monitoring System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Expression MR400 MRI Patient Monitoring System as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power Of Transmitter (W) Separation Distance According To Frequency Of Transmitter (m) 150 KHz to 80 MHz d = (3.5/V1) 80 MHz to 800 MHz d = (3.5/E1) 800 MHz to 2.5 GHz d = (7/E1) 0.01 0.117 0.117 0.233 0.1 0.369 0.369 0.738 1.167 1.167 2.333 10 3.689 3.689 7.379 100 11.667 11.667 23.333 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. • At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Using Batteries Safely Batteries have life cycles. The battery life is at an end when the equipment operating time provided by battery power becomes much shorter than usual (i.e., when the total battery capacity has only 70 percent its initial capacity). For optimal battery life, please follow these guidelines: • Do not store the batteries in a discharged condition. Always charge a battery to at least 40 percent of capacity before storing. • Charge the batteries once a month when not in use. Immediately remove any battery that has an expired life cycle and replace it with a new battery of the same type. (Refer to page 1‐37 for part numbers.) To ensure the safety of operators and patients, observe the following warnings and cautions. 1‐12 Important Information Expression MR400 Instructions for Use WARNING Warning Do not use a damaged battery. Periodically check batteries, stop using and replace any battery that exhibits abnormal heat, odor, color, deformation, or other condition. If a battery is punctured or if battery liquid leaks onto your skin or clothing, immediately wash the area and clothing with fresh water. If battery liquid gets into your eyes, do not rub your eyes; immediately flush your eyes with clean water and consult a physician. Caution CAUTIONS • If the battery contacts become dirty, wipe them clean with a dry cloth before use. Do not immerse in a battery in water or other liquids. • Store batteries in a dry place, between 0 to 40°C (32 to 104°F) . Do not expose a battery to temperatures above 60°C (140°F). • Do not short the external battery contacts. Keep metal objects away from the battery contacts. • Store each battery in a manner that prevents shorting with the container or another cell/ battery. • Only use the Philips specified charger. Examining the Shipment To report shipping damage, or to resolve any issues or concerns with your order, contact Customer Service. (Save all packing materials and related shipping documents, as these may be required to process a shipping damage claim with the carrier.) After removing the contents from the shipping containers, carefully examine all items for signs of damage that may have occurred during shipment. Also, check all items against the included packing list and the purchase request. The contents of the crate should include: • Expression MR400 MRI Patient Monitoring System • Two main batteries • Instructions for Use (IFU) manual • Quick Reference Guide (included in English‐localized shipments only) • Power Cord A separate container may include additional items: • Wireless ECG patient module (Gen 3) • Wireless SpO2 patient module (Gen 3) Expression MR400 Instructions for Use Important Information 1‐13 • Module battery charger • Module batteries Disposing of the Packaging The packaging can be retained for future use. Otherwise, the packaging for the system (which is made of recyclable materials that include corrugated paper, polyethylene [PE] foam and plastic) may be subject to disposal regulations for user and environmental safety. For disposal, it may be necessary to separate these materials by type. Always observe and adhere to your current local regulations when disposing of the packaging material. Initial Setup The instructions below detail the initial setup process for a fully‐equipped Expression MR400 MRI Patient Monitoring System (hereafter referred to as the MR400)—including the wireless ECG patient module (hereafter referred to as the wECG module) and the wireless SpO2 patient module (hereafter referred to as the wSpO2 module) and hereafter referred to collectively as wireless modules. Depending upon the needs of your facility and the MR400 options purchased, the steps you follow may differ and some may not be required. For the location of components not detailed below, see chapter 2. WARNINGS • Only perform initial setup of the MR400 at a location outside of the MR magnet room. Failure to observe this warning may result in serious injury. • No modification of this equipment is allowed. Failure to observe this warning may result in serious injury. CAUTION The MR400 and accessories must be used and stored according to the environmental specifications detailed in Appendix A. Failure to adhere to the specified environmental requirements may affect system and/or accessory performance and accuracy. 1‐14 Important Information Expression MR400 Instructions for Use To perform initial setup of the MR400 Step Action Perform a visual inspection of the MR400, checking for loose or missing hardware or damage. If loose or missing hardware or damage is observed, contact technical support. Install the main batteries into the cart and connect the reserve batteries; see page 1‐16. Connect AC mains power to the MR400, but DO NOT turn on the power switch. Allow the batteries to charge for at least 12 hours before use; see page 1‐20. Note Before initial use, charge the batteries in the cart for at least 12 hours with the MR400 turned off and connected to AC mains power. If wECG and wSpO2 modules were included, perform a visual inspection of the devices for loose or missing hardware or damage. If a wSpO2 module was included, attach an SPO2 probe to it; see page 1‐18. If module batteries were included, charge the module batteries using the Philips‐specified battery charger. (Refer to the instructions provided with the charger.) Note Before initial use, charge the module batteries for at least 4 hours. Press the power switch (on the front of the cart) then verify that the MR400 has successfully powered‐up and that the power LED is steady green. For other possible indications, see page 2‐7. If equipped with an IP5, verify that the MR400 and IP5 are set to the same wireless network channel by checking the network icon (see examples below) that is displayed by each device. See page 1‐27 for MR400 network setting instructions; and, refer to the IFU for the IP5 for network setting instructions. Expression MR400 Instructions for Use If wECG and wSpO2 modules were included, install the charged module battery (or batteries) into the device(s); see page 1‐24 for the wECG module and see page 1‐26 for wSpO2 module. Important Information 1‐15 Step 10 Action Verify that the status indicator on the wECG and wSpO2 modules is illuminated steady green: • For the wECG module, see page 2‐9. • For the wSpO2 module, see page 2‐11. 11 Verify that the wireless network channels on the wECG and wSpO2 modules are set to the channel used by the MR400; see page 1‐29. 12 Place the wECG and wSpO2 modules into the module holders on the MR400; see page 2‐12. This completes the initial setup process. For information regarding other possible MR400 connections; see Rear Panel Connections on page 1‐19. Installing and Connecting Cart Batteries WARNING Warning Cart batteries contain ferrous materials that are attracted to the MR magnetic field. Do not install or remove the cart batteries when closer than the 1,000 gauss (0.1 T) field line, as measured from the center line of the MR bore to the MR400. The batteries will be attracted to the magnetic field, possibly causing patient or user injury. CAUTION Never force a main battery into a battery compartment as it will damage the battery and/or the cart. Four batteries are used in the MR400: • Two main batteries must be inserted—one into the left battery compartment and one into the right battery compartment of the cart; and, • Two reserve batteries, internally‐housed in the cart, must be switched on. To install and connect the main and reserve batteries Step 1‐16 Important Information Action Locate the battery compartments, which are underneath the WPU on the left and right sides of the cart. Expression MR400 Instructions for Use Step Action Hold a main cart battery with the label side down and with its connector facing forward. (Silk screening above each battery compartment provides the correct battery orientation—the left side is shown in the example below.) Then, slide the battery completely into the battery compartment until a “click” is heard as the battery latches into place. Battery compartment WPU Main cart battery (If the battery does not latch into place when inserted, then it is not properly oriented. In this case, remove, reorient correctly, and then reinsert the battery.) Repeat steps 1 and 2 to install the remaining main cart battery on the opposite side of the cart. Remove the shield cap from the gating connector and the two screws that secure the service panel cover to the back of the WPU then remove the service panel cover. Screws Service panel cover Shield cap Expression MR400 Instructions for Use Important Information 1‐17 Step Action Locate the battery switch and toggle it into the On (I) position. Battery switch Reinstall the service panel cover, and secure it to the WPU using the two screws. Replace the shield cap. This completes the installation and connection of the main and reserve batteries. Connect AC mains power then allow these batteries to charge for at least 12 hours before initial use; see page 1‐21. Attaching the SpO2 Probe to the wSpO2 Module The SpO2 probe, necessary for taking SpO2‐related measurements using the wSpO2 module, must be connected prior use. WARNINGS • Only perform this attachment at a location outside of the MR magnet room. Failure to observe this warning may result in serious injury. • Connecting an other than specified SPO2 probe to the wSpO2 module can cause inaccurate SPO2 readings and damage the module. To attach the SPO2 probe Insert the SPO2 probe connector into the DB‐9 connector on the wSpO2 module then securely tighten both screws. 1‐18 Important Information wSpO2 module DB-9 connector SPO2 probe connector Screws Expression MR400 Instructions for Use Rear Panel Connections Depending upon the options included with your MR400 or the use model, some connections may be required after moving the MR400 into the MR magnet room. In addition to the connection for AC mains power, connections for the waste gas port and the gating cable are available on the rear panel of the MR400. (For information about the placement of the MR400 in the MR magnet room, see page 3‐2.) CAUTION When making connections to the rear panel of the MR400, ensure that the final installation complies with IEC 60601-1, clause 16, Medical Electrical (ME) Systems, to assure operator and patient safety. Always check the summation of leakage currents when the MR400 is connected to additional external equipment. Where the integrity of the external protective conductor in the installation or its arrangement is in doubt, the MR400 shall be operated from batteries. Gating connector for gating control connections to the MR system. (Gating cables are type-dependent; see page 1-35.) Waste gas port (if equipped) for connection of exhausted sampled respiratory gases from the MR400 to your facility’s gas scavenging system; suggested tubing requirement: 3.175 mm (0.125 inch) outer diameter, 1.6 mm (0.063 inch) inner diameter. Ground lug (equipotential ground [earth] connection point) Expression MR400 Instructions for Use • allows for electrical safety testing; and, • allows authorized service personnel to connect a ground strap for prevention of ESD during servicing. Important Information 1‐19 4 Strain relief for retention of the power cord. AC receptacle for connection of the power cord. Connecting AC Mains Power When connecting the MR400 to the mains electrical supply, do not route the detachable power cord where it will be an obstruction or stepped upon. Do not block access to the MR400 with other equipment and never position the MR400 in such a way that would make it difficult to unplug. WARNINGS • Only use the supplied power cord and connect to properly grounded AC outlets to avoid electrical shock. • Avoid use of electrical extension cords or multiple portable socket outlets, which may create a safety hazard by compromising the grounding integrity of the MR400. To connect AC mains power Step Action Ensure that all cart batteries are installed and switched on; see page 1‐16 for details. If placing the MR400 in the MR magnet room, position the MR400 at a proper location; see page 3‐2. Raise the strain relief; see page 1‐20 for the location. Plug the power cord into the AC receptacle on the MR400; see page 1‐20 for the location. For added mobility, the power cord extension (REF 989803168221) can also be connected. Lower the strain relief over the power cord. Plug the power cord into an approved AC mains outlet. To remove the MR400 from AC mains power Pull the plug of power cord from the AC wall outlet. Then, lift the strain relief and remove the power cord from the AC receptacle on the rear of the MR400. Store the cord in a safe place. 1‐20 Important Information Expression MR400 Instructions for Use Understanding Battery Operations Cart Batteries WARNING Warning Do not touch the patient and the circuitry in the battery compartments of the MR400 simultaneously. Cart batteries, when installed (main) and switched on (reserve), are charged and conditioned by an integrated charging system. When turned on and connected to AC mains, the MR400 operates from AC power and simultaneously charges all cart batteries. When turned off and connected to AC mains, battery charging functions continue. If at any time, AC mains is lost, the MR400 will automatically switch to battery power to provide uninterrupted service—then, when AC mains is restored, the MR400 will automatically, without delay, revert back to AC power functions. If the reserve batteries are fully depleted and AC mains is lost, then the unit will power off. The MR400’s maximum operating time on battery power depends upon the enabled parameters and the type and frequency of monitoring functions (see the Battery, Operation Time on page A‐4 for a listing). Charging Cart Batteries Cart batteries must be charged before initial use. During initial setup or when installing new batteries, charge the cart batteries for at least 12 hours so that they are fully charged and conditioned for operation. Notes • Use only with the specified battery charger. • The main batteries must always be inserted and the reserve batteries must always be switched on to prevent loss of patient monitoring during a power outage. If main batteries are not inserted and if the reserve batteries are not switched on, then during power outage unsaved user settings will revert to factory defaults. • We recommend plugging the MR400 into a backup generator or equivalent means to prevent a lapse in patient monitoring during a power loss. Expression MR400 Instructions for Use Important Information 1‐21 To charge the cart batteries Step Action Ensure that all cart batteries are installed and switched on. See Installing and Connecting Cart Batteries on page 1‐16 for details. Connect the MR400 to AC mains power. See Connecting AC Mains Power on page 1‐20. Ensure that the MR400 is turned off and that it remains off for the next 12 hours. Charged capacity of all cart batteries can be displayed; see the Status Information Panel on page 2‐18). Charged capacity can also be found by pressing the power level button on each main cart battery, where the current level is provided by the charge indicator; see Removing Cart Batteries, below. Charge indicator Power level button Cart battery Removing Cart Batteries To remove the main batteries Step 1‐22 Important Information Action Locate the battery eject button, which is in a recessed area under each battery compartment on the left and right sides of the cart. Expression MR400 Instructions for Use 2 Press the battery eject button to partially eject a main battery from the battery compartment, and then grasp the battery and pull to remove it completely from the MR400. Battery compartment Battery eject button Main battery (If the battery does not release, apply a slight forward pressure to the battery while pressing the battery eject button.) Repeat steps 1 and 2 to remove the other main cart battery on the opposite side of the MR400. Note The reserve batteries cannot be removed, but can be switched off. For instructions on the complete removal of power to the MR400, see page 14-2. Wireless Module Batteries Module batteries provide power to the wECG and wSpO2 modules. Module batteries are interchangeable, non‐magnetic, and can be handled safely in the MR magnet room. CAUTION To minimize the chance of image artifacts, never place module batteries in the MRI field of view. Expression MR400 Instructions for Use Important Information 1‐23 Charging Module Batteries Module batteries must be charged for at least 4 hours before initial use. Module batteries are charged in the Philips‐specified battery charger. Refer to the instructions provided with this battery charger for information. Installing Batteries in the wECG Module The wECG module can accept up to two batteries. Depending upon the number of batteries installed, the wECG module provide different operational features: • If one battery is installed, then the wECG module will turn on and function normally—but before its charge is exhausted, a second battery must be installed in order to continue the ECG study. • If two batteries are installed, then seamless operation is possible—one battery will provide power until its charge is exhausted, at which time the wECG module will automatically switch to the remaining battery for continued operation. As long as sufficient power is provided by the second battery, continued operation is possible. And, an exhausted battery can be replaced at any time without interruption to the ECG study, provided that sufficient charge is present on the remaining battery. • Indicators identify the source battery being used by the wECG module; see page 2‐9. • When both batteries are removed, the wECG module will turn off. To install batteries in the wECG module Step Action Hold the wECG module so that its battery bays are oriented as shown, with battery bay 1 in the lower position and battery bay 2 in the upper position. wECG module Bay 2 Bay 1 1‐24 Important Information Expression MR400 Instructions for Use Step Action Orient a module battery so that the tip of the battery arrow aligns with the tip of the bay 1 arrow on the wECG module. Then slide the module battery into bay 1, pressing until it seats completely. Bay 1 arrow Module battery Battery arrow Orient a module battery so that the tip of the battery arrow aligns with the tip of the bay 2 arrow on the wECG module. Then slide the module battery into bay 2, pressing until it seats completely. Bay 2 arrow Module battery Battery arrow Removing Batteries from the wECG Module To remove battery 1 from the wECG module Press a battery eject button 1 (item 1, right). Then grasp the partially ejected module battery (item 2) and pull to remove it. Expression MR400 Instructions for Use Important Information 1‐25 To remove battery 2 from the wECG module Press a battery eject button 2 (item 3, right). Then grasp the partially ejected module battery (item 4) and pull to remove it. Installing a Battery in the wSpO2 Module The wSpO2 module uses one battery. When a module battery is inserted, the wSpO2 module will turn on. And, when the battery is removed, the wSpO2 module will turn off. To install a battery in the wSpO2 module Step Action Hold the wSpO2 module so that its battery bay is oriented as shown. wSpO2 module Battery bay Orient a module battery so that the tip of the battery arrow aligns with the tip of the bay arrow on the wSpO2 module. Then slide the module battery into the battery bay, pressing until it seats completely. Bay arrow Module battery Battery arrow 1‐26 Important Information Expression MR400 Instructions for Use Removing the Battery from the wSpO2 Module To remove the battery from the wSpO2 module Press the battery eject button (item 1, right). Then grasp the partially ejected module battery (item 2) and pull to remove it. Understanding Wireless Network Operations A wireless network channel is used for system communication between the MR400 cart and the wECG and wSpO2 modules (and, if equipped, the IP5). All wireless devices must use the same wireless network channel for proper system communications. Also, where multiple Invivo (Royal Philips) MRI patient monitoring systems are in use, the selected wireless network channel should be not used by any other system in your facility (for the frequency range, see page 1‐8). Setting the Wireless Network Channel of the Cart All controls for selecting the wireless network channel of the MR400 are located on the cart’s touch screen. Unique symbols and numbers are used to identify each available channel for the MR400, as shown below. Expression MR400 Instructions for Use Network channel 1 Network channel 6 Network channel 2 Network channel 7 Network channel 3 Network channel 8 Network channel 4 Network channel 9 Network channel 5 Network channel 10 Important Information 1‐27 WARNINGS • Care should be taken to guard against inadvertent changes to the network channel setting. Before use, always ensure that all devices are communicating properly. Failure to do so may cause a lapse in patient monitoring. • An MR400 system is comprised of one MR400 cart, one wECG module, and one wSpO2 module, and optionally an IP5. In environments where multiple MR400 MRI patient monitoring systems are being used, you must be aware of each component’s network setting. Operating multiple MR400 systems on the same network or with a wrong network setting will interfere with communications, and incorrect or corrupted patient vital signs information will be displayed as a result. Notes • If a patient is currently admitted, a warning dialog box will prompt you before a change to the monitor network is allowed. • After changing the wireless network channel of the MR400, you must wait a minimum of 5 seconds before removing power from the system; otherwise, the change will be lost. To set the wireless network channel for the MR400 cart Step Action Press the power switch (see page 2‐7 for the location) then allow the MR400 to initialize. The main screen appears. Select the network icon. Network menu Network icon The network menu appears. 1‐28 Important Information Expression MR400 Instructions for Use Step Action Select the desired setting from the options: 10 The setting is entered and the network icon is changed to the current selection. Ensure that the network channel used by the wECG and wSpO2 modules (see page 1‐29) and the IP5 (if equipped) are identical to the network setting of the cart. Setting the Wireless Network Channel of the wECG and wSpO2 Modules All indicators and controls for wireless network channel selection are located on the front of the wireless modules. Two different groups of five wireless network channels are available (channels 1–5, or channels 6–10) and both modules must be of the same group, depending upon your selection at time of purchase. Note The wECG and wSpO2 modules may arrive preprogrammed to match the network channel setting of your MR400, thus eliminating the need to change the channel setting. The wireless network channel for a module is changed by using the network selection button. The wireless network channel for a module should be set to match the wireless network channel used by the MR400; see page 1‐27. Network channel indicators Network selection button The following directions for changing the wireless network channel apply to both wireless modules and to either channel group, though the process below depicts the wSpO2 module and channel group 1– 5. (For more operational details about the wECG module, see page 2‐9; and, for the wSpO2 module, see page 2‐11.) Expression MR400 Instructions for Use Important Information 1‐29 Before starting the procedure to change the network channel of the wireless module, take note of these conventions that are used to explain the process: • The following symbols are used to convey the state of the network channel indicator on a wireless module. Symbol illuminated • Symbol blinking The following illustrations are used to convey actions concerning the use of the network selection button. Pressing the button Pressing and holding the button Releasing the button Repeating To set the wireless network channel of the wECG or wSpO2 module Step Action Turn off the wireless module: • wECG module—see Removing Batteries from the wECG Module on page 1‐25. • wSpO2 module—see Removing the Battery from the wSpO2 Module on page 1‐27. Turn on the wireless module: • wECG module—see Installing Batteries in the wECG Module on page 1‐24. • wSpO2 module—see Installing a Battery in the wSpO2 Module on page 1‐26. The network channel indicators will flash briefly and then the current network channel indicator will illuminate (for example, “3” in the illustration below). 1‐30 Important Information Expression MR400 Instructions for Use Step Action Enter the network channel change mode: After the current network channel indicator has been illuminated (and within 10 seconds of module power‐up), press and hold the network selection button until the current network channel indicator begins to rapidly blink then release the button. Note If the network channel change sequence was not started within 10 seconds after the module has been turned on, network channel changes will not be allowed. In this case, you must cycle module power and restart the sequence. Press down again on the network selection button until the symbol stops blinking and then release the button to change the network channel setting. When you do this, the next network channel indicator in the sequence will blink rapidly. (In other words, if the module was originally using network channel “3,” now the “4” symbol will be blinking.) Repeat this sequence of pressing down and releasing the button until the symbol of the network channel you prefer is rapidly blinking. If you pass the desired channel, simply continue pressing and releasing the button until the desired network channel indicator is blinking again. Expression MR400 Instructions for Use Important Information 1‐31 Step Action When you reach the desired symbol, press and hold the button for approximately 5 seconds to lock and save the new setting. The selected network channel's symbol will turn off while the button is depressed. Then it will illuminate (not blink) when the new network channel setting is saved. Once illuminated, release the button. The module will begin using the selected network channel. Note Any part the network channel change sequence not completed will cause the module to revert to the network channel previously set 30 seconds after the network selection button was last released. 1‐32 Important Information Expression MR400 Instructions for Use Advanced User Options Expression Information Portal (Model IP5) Providing system control outside the MR magnet room, the Expression Information Portal (Model IP5), hereafter referred to as the IP5, is a wireless device that also features printing capabilities and HL7 data output options. The MR400 uses a wireless connection for communication with the IP5. The IP5’s connection to the hospital information system (HIS) is explained in detail in the IP5 IFU. When using the IP5 to connect to the HIS, adhere to all cautions and safety instructions found in the IP5 IFU. Additional Options Additional options may be suggested by your biomedical technician to increase user ease. Consult your biomedical technician or technical support with specific requests. Caution CAUTIONS • When adding equipment to an MR400 system (for example, an IP5), be aware that all devices should be at the same or a compatible software revision level. Contact technical support if you have questions or to upgrade software. Failure to observe this requirement could result in compatibility conflicts, communication problems, et cetera. • Unauthorized modification to the radios/and/or antennas may cause the device to no longer be in compliance with applicable regulatory standards • The manufacturer is not responsible for any radio frequency interference caused by unauthorized modifications to the radios and/or antennas within this equipment. Such modification could inhibit proper MR400 system or device communications. Accessory List Accessories are listed in the tables below with part number (REF) information. Where applicable, the original part number has also been included for reference. For additional information about these accessories, please consult the documentation that accompanies the accessory. Expression MR400 Instructions for Use Important Information 1‐33 WARNING Warning The MR400 has been validated with all of the accessories listed below. Only use these specified accessories as other types or brands may compromise the safety and accuracy of the MR400. Patient injury or loss of monitoring may result if incorrect accessories are used. WARNING Warning Do not use sterile items if the packaging is damaged. Patient injury may result if non-sterile accessories are used. CAUTION Modifications to the MR400 System during its service life are required to be evaluated to the requirements of IEC 60601-1. AGENT Original Part Number REF CANNULA, DISP, ADULT 9012 989803152561 CANNULA, DISP, ADULT 9016 989803152601 CANNULA,DISP,INT INF,(DIVIDED) 9016B 989803152621 CANNULA,DISP,PED,(DIVIDED) 9016C 989803152631 CANNULA,DISP,INFANT,(DIVIDED) 9016A 989803152611 CANNULA, DISP, INT INFANT 9015 989803152591 CANNULA, DISP, PED 9013 989803152571 CANNULA, DISP, INFANT 9014 989803152581 — 989803162051 KIT,DISPOSABLE WATER TRAP,3160 94012 989803152671 KIT,SAMPLE,AGENTS,3160 94018 989803152661 ANESTHETIC OXYGEN (O2) SENSOR CO2 REF LOFLO SAMPLE LINE, ADULT CANNULA, BOX 20 989803183241 LOFLO SAMPLE LINE, PED. CANNULA, BOX 20 989803183251 LOFLO SAMPLE LINE, NEO. CANNULA, BOX 20 989803183261 LOFLO LINE, ADU DVD CANNULA,BOX 20 989803183271 1‐34 Important Information Expression MR400 Instructions for Use CO2 REF LOFLO LINE, PED DVD CANNULA, BOX 20 989803183281 LOFLO LINE, ADU AIRWAY ADPT, BOX 20 989803183291 LOFLO SAMPLE LINE, ADULT CANNULA,BOX 100 989803185331 LOFLO SAMPLE LINE, PED CANNULA, BOX 100 989803185341 LOFLO SAMPLE LINE, NEO CANNULA, BOX 100 989803185351 LOFLO LINE, ADU DVD CANNULA, BOX 100 989803185361 LOFLO LINE, PED DVD CANNULA, BOX 100 989803185371 LOFLO LINE ADU AIRWAY ADPT, BOX 100 989803185381 ECG Original Part Number REF 9009 989803152291 EXPRESSION MR ECG LEADS, AAMI, CV — 989803193721 EXPRESSION MR ECG LEADS, AAMI, STANDARD — 989803193731 EXPRESSION MR ECG LEADS, AAMI, NEONATAL — 989803193741 EXPRESSION MR ECG LEADS, IEC, CV — 989803193751 EXPRESSION MR ECG LEADS, IEC, STANDARD — 989803193761 EXPRESSION MR ECG LEADS, IEC, NEONATAL — 989803193771 QUADTRODE MRI ECG PAD, 25/BOX — 989803179031 ELCTRD, MRI ECG, QUTRD.CV, 25/BOX — 989803179041 ELCTRD, MRI, NEO.QUDTRD, 25/BOX — 989803179051 WIRELESS ECG PATIENT MODULE (GEN 3) 1-5 — 989803192761 WIRELESS ECG PATIENT MODULE (GEN 3) 6-10 — 989803194341 Original Part Number REF CAB, DIGITAL GATING, GE, 3160 9292 989803152821 CAB, GATING, SIEMENS, 3160 9291 989803152831 — 989803195521 9293 989803152851 GEL, ECG/EEG, SKIN PREP, TUBE, 3-PACK Gating UNIVERSAL GATING INTERFACE CAB, DIG.GATING, HIT/TOSH, 3160 Expression MR400 Instructions for Use Important Information 1‐35 Invasive Blood Pressure REF EXPRESSION MR IBP TRANSDUCER CABLE, 5FT 989803194601 EXPRESSION MR IBP DPT KIT, A/P, BOX 20 989803194631 EXPRESSION MR IBP DPT KIT, I/N, BOX 20 989803194641 (Note that Hospira [Transpac models], and Edwards Lifesciences [Transducer, Model PX260 and adapter cables], have also been qualified for use. Please contact Hospira or Edwards Lifesciences for information about Invivocompatible devices, and contact your sales representative with any questions.) Non-invasive Blood Pressure (NIBP) REF NIBP CUFF, SINGLE LUMEN, INFANT 989803182611 NIBP CUFF, SINGLE LUMEN, PEDIATRIC 989803182621 NIBP CUFF, SINGLE LUMEN, SMALL ADULT 989803182631 NIBP CUFF, SINGLE LUMEN, ADULT 989803182641 NIBP CUFF, SINGLE LUMEN, ADULT-L 989803182651 NIBP CUFF, SINGLE LUMEN, LRG ADULT 989803182661 NIBP CUFF, SINGLE LUMEN, LRG ADULT-L 989803182671 NIBP CUFF, SINGLE LUMEN, THIGH 989803182681 NIBP CUFF, SINGLE LUMEN, INFANT, DISP 989803182511 NIBP CUFF, SINGLE LUMEN, PEDIATRIC, DISP 989803182521 NIBP CUFF, SINGLE LUMEN,SMALL ADULT,DISP 989803182531 NIBP CUFF, SINGLE LUMEN, ADULT, DISP 989803182541 NIBP CUFF, SINGLE LUMEN, ADULT-L, DISP 989803182551 NIBP CUFF, SINGLE LUMEN, LRG ADULT, DISP 989803182561 NIBP CUFF, SINGLE LUMEN,LRG ADULT-L,DISP 989803182571 NIBP CUFF, SINGLE LUMEN, THIGH, DISP 989803182581 NIBP CUFF, SINGLE LUMEN, NEO #1, DISP 989803183171 NIBP CUFF, SINGLE LUMEN, NEO #2, DISP 989803183181 NIBP CUFF, SINGLE LUMEN, NEO #3, DISP 989803183191 NIBP CUFF, SINGLE LUMEN, NEO #4, DISP 989803183201 NIBP CUFF, SINGLE LUMEN, INFANT #5, DISP 989803183211 1‐36 Important Information Expression MR400 Instructions for Use Non-invasive Blood Pressure (NIBP) REF ADULT PRESSURE INTERCONNECT HOSE 989803183221 NEONATAL PRESSURE INTERCONNECT HOSE 989803183231 Respiration (Pneumatic) PNEUMOGRAPH,CHEST,NM,3160 SPO2 Original Part Number REF 94023 989803152791 REF QUICK CONNECT SPO2 PROBE, MRI 989803161991 QUICK CONNECT SPO2 CLIP, ADULT 989803166531 QUICK CONNECT SPO2 CLIP, PEDIATRIC 989803166541 QUICK CONNECT SPO2 GRIP, ADULT, 20/BOX 989803166551 QUICK CONNECT SPO2 GRIP, PED, 20/BOX 989803166561 QUICK CONNECT SPO2 GRIP, INFANT, 20/BOX 989803166571 QUICK CONNECT SPO2 GRIP, NEO, 20/BOX 989803166581 WIRELESS SPO2 PATIENT MODULE (GEN 3) 1-5 989803192771 WIRELESS SPO2 PATIENT MODULE (GEN 3) 6-10 989803194331 System REF BATTERY, MODULE (GEN 3) 989803191341 BATTERY, MRI, 14.8V, 5.08 AH, UL 989803169491 EXPRESSION INFORMATION PORTAL (IP5) 865471 ADVANCED COMMUNICATIONS OPTION 989803176521 EUROPEAN LINE CORD 453564177501 NORTH AMERICAN LINE CORD 989803168211 CORD, JUMPER, 25 FEET 989803168221 BRAZILIAN POWER CORD, 3 METER 989803173901 UK LINE CORD, 3 METER 989803174171 POWER CORD, AUS/NZL, 3 METER 989803181291 POWER CORD, S AFRICA, 3 METER 989803181321 Expression MR400 Instructions for Use Important Information 1‐37 System REF POWER CORD, DANISH, 3 METER 989803181331 POWER CORD, ISRAELI, 3 METER 989803181341 POWER CORD, ARGENTINA, 3 METER 989803181351 POWER CORD, SWISS, 3 METER 989803181361 Temperature REF FLEXTEMP II SENSOR (ESOPHAGEAL/RECTAL/AXILLARY, DIRECT MODE) 989803194511 SURGICAL LUBRICANT, 12 PACK 989803168891 FLEXTEMP SYSTEM, JACKET (BOX 10) 989803178181 Miscellaneous REF MR400 QUICK REFERENCE GUIDE 453564557591 MANUAL, SERVICE, MR400 989803195211 MANUAL, OPERATOR, MR400, DANISH 989803193191 MANUAL, OPERATOR, MR400, DUTCH 989803193201 MANUAL, OPERATOR, MR400, ENGLISH 989803193211 MANUAL, OPERATOR, MR400, FINNISH 989803193221 MANUAL, OPERATOR, MR400, FRENCH 989803193231 MANUAL, OPERATOR, MR400, GERMAN 989803193241 MANUAL, OPERATOR, MR400, INDONESIAN 989803193251 MANUAL, OPERATOR, MR400, ITALIAN 989803193261 MANUAL, OPERATOR, MR400, JAPANESE 989803193271 MANUAL, OPERATOR, MR400, KOREAN 989803193281 MANUAL, OPERATOR, MR400, NORWEGIAN 989803193291 MANUAL, OPERATOR, MR400, POLISH 989803193301 MANUAL, OPERATOR, MR400, PORTUGUESE 989803193311 MANUAL, OPERATOR, MR400, RUSSIAN 989803193321 MANUAL, OPERATOR, MR400, SPANISH 989803193331 MANUAL, OPERATOR, MR400, SWEDISH 989803193341 1‐38 Important Information Expression MR400 Instructions for Use Miscellaneous REF MANUAL, OPERATOR, MR400, TRAD. CHINESE 989803193351 MANUAL, OPERATOR, MR400, TURKISH 989803193361 Expression MR400 Instructions for Use Important Information 1‐39 1‐40 Important Information Expression MR400 Instructions for Use CHAPTER 2 System Overview The MR400 is designed to provide multi‐vital sign patient monitoring and MRI gating capability in the MRI environment while in close proximity to an MRI scanner magnet. The monitoring capabilities of the MR400 can be configured to meet the needs of a wide spectrum of patients from neonate to adult. Every parameter can be accessed and adjusted for the unique condition of each patient. The MR400 accommodates specific monitoring needs, including: • Adult, pediatric and neonatal patients • Critically ill patients • Patient undergoing sedation • Patient transport within the MR environment • Interventional procedures • Cardiac gating Note We recommend the establishment of a program for supervision appropriate to the classes and types of patients, and that all patients should receive at least routine monitoring when the MR400 is in use. System Parameters The MR400 simultaneously processes and displays multiple parameters, waveforms, measurement numeric values and alarms. All patient information is provided on the touch screen. A fully equipped MR400 includes monitoring for the following parameters: • Electrocardiogram (ECG), dual channel • Heart rate (HR) • Blood oxygen saturation/pulse oximetry (SPO2) • End‐tidal and fractional inspired CO2 (EtCO2 and FiCO2) • Invasive blood pressure (P1 and P2) • Anesthetic agents (AGENT) • Fractional inspired O2 (FiO2), and end‐tidal and fractional inspired N2O (EtN2O and FiN2O) • Temperature (TEMP) Expression MR400 Instructions for Use System Overview 2‐1 • Non‐invasive blood pressure (NIBP) • Respiration rate (CO2 or bellows) Note Depending upon the equipped options, your MR400 may not have all indicated parameters. System Components Before use, familiarize yourself with the MR400 and its components. A complete MR400 system consists of the following components: • MR400 cart • wECG module • wSpO2 module • Module battery charger • Batteries and other accessories as needed • Optional: IP5 with or without a printer Use Model The MR400 is intended to be used to monitor the vital signs of a patient in an MR magnet room, as illustrated below. The wECG and wSpO2 modules communicate via wireless links to supply the patient’s measured ECG, SPO2, and bellows‐derived respiration signals to the MR400. The gating cable is only required for MRI triggering and synchronization based on the patient’s ECG or SPO2 signals. When paired with an optional IP5, monitoring capability can be extended via wireless link to an MR control room, induction room, or recovery room environment. Data transmitted from the MR400 to an IP5 can be output to an optional strip chart printer or to the hospital information system (HIS). 2‐2 System Overview Expression MR400 Instructions for Use MRI magnet room MR400 Gating cable Modules to MR400 (wireless) Patient table HIS system MR400 to IP5 (wireless) MRI control room IP5 Printer USB Ethernet Hospital network Acquisition and Control Use of the MR400 is restricted to one patient at a time. The MR400 displays patient measurements acquired during monitoring. Controls and settings for patient monitoring are provided locally on the touch screen or remotely (for example, in the MRI control room) when equipped with the IP5, where connections for the printer and the hospital network are also available. Synchronization The MR400 will automatically establish communication with the wireless modules, and IP5 (if equipped). However, due to the use model, the devices can establish communication and synchronize power‐on settings according to the start‐up sequence: • If the MR400 boots and communicates first, then its settings will be reflected at the IP5. • If an IP5 boots and communicates first, then its settings will be reflected at the MR400. If using an IP5, patient identifiable information (name and ID number) will be available after synchronization occurs. Expression MR400 Instructions for Use System Overview 2‐3 WARNINGS • The use model specifies one IP5 per MR400 system. If more than one IP5 is present on the MR400 system, there is an increased risk of units within the system not synchronizing and displaying incorrect or corrupted settings. • The MR400 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system must be observed to ensure normal operation in the configuration in which it will be used. CAUTION If the monitor’s settings are adjusted since they were last recalled or stored (manually, or via synchronization if using an IP5), the User Settings key (see page 2-15) will be appended with a plus symbol (+). The symbol will only be removed if the current settings are saved (see page 3-15) or if different settings are recalled (see page 3-26). Always confirm the proper settings for the MR400 and IP5 to ensure expected monitoring functionality. Note See Default Settings (on page 3-7) for information about the system’s power-on setup. Device Control Menu commands that control parameter functions for patient monitoring are synchronized between the MR400 and IP5. Commands that do not directly control patient parameters (for example, printer functions) will only affect the IP5. Other control settings remain localized to the IP5 and are not synchronized with the MR400, including the alarm audio off and alarm audio pause functions, and the volume settings; see the IP5 IFU for a complete listing. Note If a systemic failure of the processing hardware, software or communications renders an intended task incomplete and unperformed, a watchdog circuit will automatically shutdown power to the WPU portion of the MR400. This will result in the removal of all patient data and displayed information, and a continuous alarm will sound until power to the MR400 is turned off. If this problem persists, contact technical support. 2‐4 System Overview Expression MR400 Instructions for Use Hardware Features Cart Designed for use in the MR magnet room and throughout the MR suite, the MR400 is a self‐ contained mobile patient monitoring system. The MR400 features a wheeled‐cart design with four large lockable casters under its aluminum frame and includes integrated systems for processing, power, display and control, as outlined below. 10 1 Display panel (see page 2-6 for details). 2 Guide handles provides the means for positioning the cart; see page 3-2 for details. 3 Patient connection panel (see page 2-7 for details). 4 Accessory hooks provide storage for sampling lines, cables, et cetera. 5 Battery compartments house the main batteries; see page 1-16 details. 6 Casters with wheel locks that, when engaged, prevent movement of the cart. Expression MR400 Instructions for Use System Overview 2‐5 7 Storage basket provides storage for Quadtrodes, cuffs, SPO2 attachments and other small accessories; see page 2-12 for details. 8 Module holders provide storage for the wECG and wSpO2 modules; see page 2-12 for details. 9 Wireless processing unit (WPU) houses the communication, processing and power systems for the MR400. 10 Rear panel houses connections for AC mains power, earth ground, gating, USB port (service use only), (optional) waste gas output, and (optional) O2 sensor. Display Panel The display panel includes a touch screen LCD (liquid crystal display), the alarm indicators and an audio speaker. The display panel can be tilted backward or forward to achieve the best viewing angle and reduce any glare on the touch screen produced by ambient lighting. CAUTION Never use the display panel to position the MR400; severe damage or failure can result. Only use the guide handle to position the MR400. If breakage of the display panel glass does occur and you contact the liquid crystal by chance, please wash it from your skin using soap and water. 2‐6 System Overview Touch screen provides displayed information and control of the MR400, and can be used with gloved fingers. Alarm light provides a visual indication of an alarm condition. Speaker provides all audible indications. USB port provides service-related functions. Expression MR400 Instructions for Use Patient Connection Panel The patient connection panel contains the power switch and LED, and input connections for various patient accessories. Note The illustration shown below features a composite of all available options. Your MR400 will not have all of these options. NIBP interconnect hose port (Optional) Loflo CO2 sampling line port (Optional) Temperature port (Optional) AGENT sample port (Optional) AGENT water trap (Optional) Invasive blood pressure ports (P1 and P2) Power switch (standby switch) is a push-type latching switch that controls power (AC mains or batteries) to the MR400 Power LED indicates the power source and power status of the MR400, as detailed in the table below Power LED Expression MR400 Instructions for Use Condition / Meaning Color State Power Source Power Switch None Off None (batteries may be installed) Off Green Steady Depending upon power source: On • If AC is present, then AC mains • If AC is not present, then batteries System Overview 2‐7 Power LED Condition / Meaning Power Switch Color State Power Source Red Steady Power fault detected; contact technical support. N/A Blue Blinking Batteries are charging Off Blue Steady Batteries at full charge Off wECG and wSpO2 Modules The wECG and wSpO2 modules are battery powered and communicate with the MR400 through a bidirectional 2.4 GHz RF link, which is automatically established approximately 30 seconds after power is applied to the module. These wireless modules operate at a distance of up to 9.1 m (30 feet) from the MR400 cart when all devices are placed within the same MRI room or within the same shielded room. The network channel and battery indicators denote the selected network channel and the battery status for each wireless module. After communications have been established, all module‐dependent vital sign information will be displayed within 10 seconds on the MR400. WARNING The system use model specifies one wECG module and one wSpO2 module per MR400 system network channel. If more than one type of each module is communicating on the same network channel, then waveform and measurement corruption will occur. 2‐8 System Overview Expression MR400 Instructions for Use wECG Module The wECG module transmits measured ECG signals through the RF link to the MR400, where two ECG signals can be displayed and are available for interfacing with the MR system cardiac gating input. The module also receives information from the MR400 to perform commanded tasks (for example, lead view and filter mode selections). Battery 1 eject button Batteries Battery 2 eject button Battery 1 indicator Battery 2 indicator Network channel indicators (1–5, in this example) Network selection button ECG lead cable connector wECG Module Indicators Battery indicators provide charge status indications for each battery used by the wECG module, as detailed in the table below. Notes • A battery time-remaining counter is displayed by the MR400; see page 2-16 for details. • For battery replacement details, see page 1-24. wECG Battery Indicator Expression MR400 Instructions for Use Color Charge Status None Battery not installed in battery bay 1, or the battery’s charge is insufficient to power the module Green Battery installed in battery bay 1 has sufficient charge Red Battery installed in battery bay 1 has low charge None Battery not installed in battery bay 2, or the battery’s charge is insufficient to power the module Green Battery installed in battery bay 2 has sufficient charge Red Battery installed in battery bay 2 has low charge System Overview 2‐9 Network channel indicator illuminates to provide the wireless network channel indication and the status of the wECG module to MR400 communications, as detailed in the table below. Notes • The communication status is also displayed by the MR400; see page 2-16 for details. • For network channel selection details, see page 1-29. Network Channel Indicator Channel Selected Network Channel Indicator Channel Selected Channel 1 Channel 6 Channel 2 Channel 7 Channel 3 Channel 8 Channel 4 Channel 9 Channel 5 Channel 10 Network Channel Indicator State Communication Status Steady Good communication Flashing No communication 2‐10 System Overview Expression MR400 Instructions for Use wSpO2 Module The wSpO2 module transmits measured blood oxygen saturation, plethysmography, peripheral pulse data and pneumatic respiration rate values through the RF link to the MR400, where the processed information can be displayed and output for interfacing to the MR system pulse peripheral and respiration gating input. Battery eject button Battery Battery indicator Network channel indicators (1–5, in this example) Network selection button Pneumatic respiration port; see page 10-2 SPO2 probe connector; see page 1-18 wSpO2 Module Indicators Battery indicator provides charge status indications for the wSpO2 module, as detailed in the table below. Notes • A battery time-remaining counter is displayed by the MR400; see page 2-16 for details. • For battery replacement details, see page 1-26. wSpO2 Battery Indicator Color Charge Status None Battery not installed or its charge is insufficient to power the module Green Battery charge sufficient Red Battery charge low Network channel indicator illuminates to provide the wireless network channel selection indication and the status of the wSpO2 module to MR400 communications, as detailed in the table below. Expression MR400 Instructions for Use System Overview 2‐11 Notes • The communication status is also displayed by the MR400; see page 2-16 for details. • For network channel selection details, see page 1-29. Network Channel Indicator Channel Selected Network Channel Indicator Channel Selected Channel 1 Channel 6 Channel 2 Channel 7 Channel 3 Channel 8 Channel 4 Channel 9 Channel 5 Channel 10 Network Channel Indicator State Communication Status Steady Good communication Flashing No communication Storing Modules and Accessories WARNINGS • Never store items containing ferrous materials on the cart or in the storage basket. Failure to observe this warning may result in serious injury. • To reduce the spread of infection, never store accessories on the cart guide handles. CAUTION When storing or removing the wECG and wSpO2 modules from the module holders, grasp only the module and never pull or apply excessive force or tension to any connected attachment. 2‐12 System Overview Expression MR400 Instructions for Use To store the wECG module and a connected ECG lead cable Loop the ECG cable trunk with foam insulator and secure it using the Velcro storage strap (see page 5‐2). Then, place the wECG module into a module holder and allow the ECG lead cable to drape. WARNING Do not use the Velcro storage strap to loop the ECG lead cable during MR scanning; otherwise, there is a risk of cable heating and possibly skin burns. CAUTION Failure to loop the Velcro storage strap on the ECG cable trunk may result in damage to the lead cable due to contact with the floor. To store the wSpO2 module and a connected probe Place the wSpO2 module into a module holder and allow the SPO2 probe to drape. To store small accessories, sample lines and the temperature sensor • Use the removable storage basket to hold small accessories (Quadtrodes, SPO2 clips and grips, et cetera). To remove the storage basket from the cart, grasp the basket and lift. • Use the accessory hooks to hang looped sample lines, the temperature sensor, et cetera. CAUTIONS • Do not place more than 2.2 kg (5 pounds) of combined weight of items in the storage basket, module holders and accessory hooks. • Never stack items onto or drape objects over the guide handle. Displayed Information and Controls The displayed information and controls for the MR400 are grouped on the touch screen according to function. Note The example below depicts information displayed by a fully-equipped MR400. Information displayed by the MR400 will vary according to the equipped options and activated parameters. If a parameter (or an ECG trace) has been turned off, its portion of the display will be blank. To turn a parameter on or off, use Parameters in the Monitor Setup menu; see page 3-18 for details. Expression MR400 Instructions for Use System Overview 2‐13 1 Information bar Soft keypad Status information pane Vital sign boxes Vital sign traces Information Bar The information bar provides general use, vital sign detection and patient information. 2‐14 System Overview 2 3 4 5 Set Time indication, and when pressed accesses the date; see page 3-13. Alarm sound state indication; see page 4-4. Heart beat detection indication (and provides a detection tone) according to the HR Tone Source setting; see page 3-21. Respiration detection indication when CO2-derived respiration is on and within specified limits, flashing at a frequency that matches the current breath rate. Expression MR400 Instructions for Use 5 Alarm Light setting indication; see 4-20. Patient information area, which displays the patient’s name and identifier (ID) when available from an IP5. Patient Type key and the current patient type setting indication; and, when pressed, accesses the Patient Type menu (see page 311). User Settings key and user settings file name indication (where the plus symbol [+] indicates that changes have occurred); and, when pressed, allows you to select a factory or a stored user setup (see Edit User Settings on page 3-15). Soft Keypad The soft keypad provides immediate access to frequently used menus and functions. 13 12 11 10 1 Main Screen key returns the MR400 to normal mode, closing any open menu, option or dialog box 2 Print key controls the remote print function and indicates the current state of the printer 3 Trends key accesses the Tabular Trends menu 4 NIBP Start/Stop key starts or stops an NIBP measurement 5 ECG Filter key accesses the ECG Filter Mode options Expression MR400 Instructions for Use System Overview 2‐15 6 Suspend key places the MR400 in suspend mode 7 Audio Pause key temporarily deactivates alarms 8 Alarm key acknowledges an active alarm 9 1-Touch Alarms key sets all alarm limits according to preset calculation values 10 NIBP Interval key accesses the automatic measurement Interval options 11 Clear Trends key clears stored trend data 12 Zero All key zeros all active invasive blood pressure channels 13 Setup key accesses the Monitor Setup, Printer, and Alarms menus Status Information Pane The status information pane provides indications for the MR400 and wireless devices: • Communication and power indications will be displayed within 2 seconds. 2‐16 System Overview Monitor network icon, which indicates the selected wireless network channel (1, in this example) and, when pressed, allows you to select the channel used by the MR400; see Setting the Wireless Network Channel of the Cart on page 1-27 for details. Indicates the battery time-remaining (given in an hours:minutes format) until power will be exhausted for the wSPO2 module; also, indicates that the wSPO2 module’s communication with the MR400 is good. Expression MR400 Instructions for Use • Indicates the battery time-remaining (given in an hours:minutes format) until power will be exhausted for the wECG module; also, indicates that the wECG module’s communication with the MR400 is good. For detailed battery information regarding the wECG module batteries, see Status Information Panel on page 2-18. Indicates the current power type used by the MR400 (AC power in this example). Indicates that an IP5 is communicating with the MR400. Power source change‐of‐state indications are displayed. Indicates a low battery condition and the approximate time (given in an hours:minutes format) until power will be exhausted for a module battery (wSpO2 in this example); also, indicates that the module’s communication with the MR400 is good. WARNING A red battery symbol indicates that the module batteries have fallen below the required operational output and module shutdown with loss of monitoring will occur. Immediately replace the module batteries to avoid a loss in monitoring. Indicates that the cart batteries are the current power type used by the MR400 and the approximate time (given in an hours:minutes format) until power will be exhausted. WARNING A red battery symbol indicates that the main batteries in the MR400 have fallen below the required operational output and system shutdown with loss of monitoring will occur. Immediately locate an AC outlet and connect the MR400 to avoid a loss in monitoring. Expression MR400 Instructions for Use System Overview 2‐17 • Indications are provided for a loss of communication, which is indicated within 2 seconds, and a no data condition (see page 2‐20) will be displayed within 10 seconds for all vital sign information missing due to a non‐communicating wireless module. Indicates that no communication is occurring between the MR400 and a wireless module (wECG in this example), or between the MR400 and the IP5. Indicates a status warning when a communication error between the MR400 and a wireless module, or between the MR400 and an IP5 is detected. Status Information Panel The status information panel provides wireless communication and power details, including the charge level of all connected batteries. To open the status information panel Select the title area (1, below) on the status information pane. 2‐18 System Overview Expression MR400 Instructions for Use Vital Sign Boxes Vital sign (VS) boxes are uniquely colored and labeled graphic frames that contain the numeric measurements and current alarm limits settings for each monitored parameter. Trending indications (arrows) are available for each monitored vital sign, except NIBP. In addition, the VS boxes (except AGENT and GAS) access the associated parameter’s menu. 10 1 ECG VS box provides electrocardiogram and heart rate measurements. 2 SPO2 VS box provides blood oxygen saturation/pulse oximetry and the heart rate measurements from pulse detection. 3 CO2 VS box provides CO2 measurements and can also provide respiration measurements. 4 P1 VS box provides invasive blood pressure measurements for channel 1 when equipped with the invasive blood pressure option. 5 P2 VS box provides invasive blood pressure measurements for channel 2 when equipped with the invasive blood pressure option. 6 GAS VS box provides the total MAC value, O2 and N2O measurements when equipped with the AGENT option. 7 AGENT VS box provides anesthetic agent measurements when equipped with the AGENT option. 8 RESP VS box provides respiration rate measurements from CO2 or the bellows accessory. Expression MR400 Instructions for Use System Overview 2‐19 9 TEMP VS box provides temperature measurements when equipped with the temperature option. 10 NIBP VS box provides non-invasive blood pressure measurements. No Data Indications Under certain conditions, no waveforms and one or more vital sign numerics may display three dashes (‐ ‐‐ ), which indicates that no data is available for the parameter(s). Depending upon the cause of this missing data, an alarm condition may be generated. No data indications that may not generate an alarm • If a module or another measurement device was just turned on or applied to the patient, allow a few seconds for communication to be established, or for any required warm‐up period to occur. • The first reading has not yet been taken or the parameter is in a start‐up condition (for example, the AGENT or CO2 monitoring hardware may be warming up). • The measurement values are distorted or the signal is inadequate (for example, the concentration of gases may be below the minimum volume percentage detectable). • Suspend mode was just exited. No data indications that may generate an alarm 2‐20 System Overview • Parameter data was present but can no longer be produced (for example, an attachment applied to a patient may have become disconnected). • The hardware associated with a parameter has experienced a problem or failure that prevents proper operation. Expression MR400 Instructions for Use Other Data Indications The Over State Indication (OVR) If the value of the numeric data item in the vital sign box is greater than the highest value specified for the item, OVR will be displayed in an alarm condition in place of the numeric. See the table on page 4‐25 for measurement range and declaration information. The Under State Indication (UND) If the value of the numeric data item in the vital sign box is less than the lowest value specified for the item, UND will be displayed in place of the numeric in an alarm condition. See the table on page 4‐25 for measurement range and declaration information. Vital Sign Traces and System Message Area Vital sign (VS) traces are uniquely colored waveforms for the ECG, SPO2, CO2 and invasive blood pressure parameters. These traces are fixed across the screen, adjustable and updated from left to right with an erase bar. The waveform color corresponds to the color of the associated VS box numeric data for that parameter. Up to six waveforms can be displayed, but if a parameter is turned off then that trace portion of the screen and VS box will be blank. System messages and some alarm flags, as detailed throughout this manual, are displayed in the center and top portions of the vital sign traces area. Multiple system messages or alarm flags will be stacked in this area. Trace A displayed as the ECG 1 waveform depending upon the selected source Trace B displayed as the ECG 2 waveform when two ECG sources are selected Trace C displays the SpO2 waveform Expression MR400 Instructions for Use System Overview 2‐21 4 Trace D displays the CO2 respiration waveform (breath rate) Trace E displays invasive blood pressure, channel 1 (P1) waveform Trace F displays invasive blood pressure, channel 2 (P2) waveform System message area displays system messages and alarm flags; see chapter 4. Navigation and Operation Everything needed to navigate and operate the MR400 can be performed by selecting an active element on the touch screen (including soft keys and buttons, icons, menus, VS boxes and alarm limits settings). When an active element is touched with a finger or a passive object (such as a stylus), the MR400 will highlight that option or item, produce a tone and enact the selection. CAUTION Never apply unnecessary pressure or use sharp objects on the touch screen as damage or failure can result. If breakage of the display panel glass does occur and you contact the liquid crystal by chance, please wash it from your skin using soap and water. Notes • Simultaneously touching two or more screen areas may produce unpredictable results and is not recommended. • The design of the MR400 allows access to the same menus in different ways. • The MR400 monitors all application processes. If a software process or an application monitoring failure is detected, then an audible alarm will sound and all visual information will be removed from the display. To restore normal operation, you must turn the power switch off and then on. If the problem persists, contact technical support. Specialized Control Buttons and Keys In addition to the control methods described above, some menus, options and items include specialized soft keys and buttons that control menus, settings and entries: 2‐22 System Overview • To decrement a numeric value, select • To increment a numeric value, select Expression MR400 Instructions for Use • To close a menu or item, select • To clear an entry field, select • To save entered data and close a menu or item, select • To enter data, save changes and close a menu or item, select Default Setting Indications The default setting of a menu appears as the highlighted item, or as the item with an asterisk in a menu. System Messages System messages are displayed to inform you about a current operation or condition, as discussed throughout this manual. Also see System Status Indications on page 4‐31. Password Protection Entry of a six‐digit password is required for access to some menus, especially service‐related menus. (Contact technical support for information.) When Enter Password: is displayed, use the keypad to enter the correct password to continue to the desired menu. Modes of Operation The MR400 has three operating modes: normal, suspend, and simulation. Normal Mode Normal mode is the standard operating mode. In normal mode there are no open menus or highlighted vital sign boxes; the system is ready for monitoring. Expression MR400 Instructions for Use System Overview 2‐23 To enter normal mode Press the Main Screen key. Any open menu will close and any highlighted VS box will be deselected (that is, the normal screen will be displayed). See page 2‐14 for an illustration. Suspend Mode WARNING Suspend mode should never be used to silence alarms or when a patient is being actively monitored as a delay in treatment and possible patient injury could result. Suspend mode supports patient‐clinician interaction without nuisance alarms, which is useful where minimal user interaction is required (for example, while a patient is not being monitored, during transitions when removing the monitor from one patient and connecting it on another, or if certain adjustments are being made to the device or other equipment). In suspend mode, current patient information is provided, but with the following operational exceptions: • Audible alarms are disabled; • Active automatic NIBP measurements are suspended; • Default inflation pressures are used for all manual NIBP readings; and, • If equipped with an IP5 and printer, automatic printouts will not be generated. To enter suspend mode Press the Suspend key. Suspended will be displayed at the center of the screen. See page 2‐20 for an illustration. To exit suspend mode Press the Suspend key. Simulation Mode Simulation mode, a password protected function, supports training and testing needs by displaying internally‐generated data for vital sign waveforms, numeric values and statuses. In simulation mode, all patient monitoring is discontinued. See page 3‐29 for menu details. 2‐24 System Overview Expression MR400 Instructions for Use CHAPTER 3 Getting Started Initial setup is important to achieve expected results and seamless operation. WARNINGS • Perform operational verification prior to use. If the MR400 fails to function properly, remove it from use and contact technical support personnel. • Do not allow the patient to move while the MR400 is being used as over-activity may result in prolonged or inaccurate readings. • Position of the accessories may affect measurement accuracy. Always consult a physician for interpretation of measurements provided by the MR400. • Do not operate the MR400 outside the specifications indicated in Appendix A as it will cause inaccurate results. CAUTIONS • A minor but noticeable degradation in wireless module communications may occur in the presence of high-powered radios. • Prior to clinical use, the user must be aware of the minimum distance from the MR magnet that must be maintained for proper operation; see Positioning the MR400 on page 3-2 for details. Defibrillator and Electrosurgical Use The MR400 has a defibrillation‐proof degree of protection that allows a patient to be defibrillated while connected to the wECG module and leads. When using a defibrillator, follow all precautions related to both the MR400 and the defibrillator equipment. During a defibrillation procedure, the ECG waveform will saturate then recover in less than 5 seconds in accordance with AAMI/ANSI EC13 and IEC 60601‐2‐27. Expression MR400 Instructions for Use Getting Started 3‐1 WARNINGS • The patient connector inputs for all parameters are protected against the use of a defibrillator by internal circuitry when the recommended patient cables or accessories are used. • Defibrillation and electrosurgery: Do not touch the patient, or table, or instruments, during defibrillation. This equipment does not provide protection against burning of the patient. • The MR400 can be used in the presence of defibrillators or electrosurgery units, provided the equipment being used is in good working order, meets appropriate safety standards, is properly grounded and is operated correctly in the appropriate manner and environment. Improperly grounded equipment can be a safety hazard and can also cause interference to the ECG signal and result in a noisy ECG signal waveform and inaccurate heart rate measurements. • Electrosurgical unit overloads may cause damage to this device. • To minimize risk of damage to the MR400 during defibrillation, use only the manufacturer’s specified accessories and supplies. • This equipment does not meet electrosurgical interference suppression (ESIS) requirements as stated in EC13, sub clause 4.2.9.14, as the ECG trace will temporarily disappear from the display during cut or coagulation bursts. CAUTION When using a defibrillator, do not introduce discharges of 360 joules or more, repeated five times over 5 minutes. Read the safety instructions provided with the defibrillator. The MR400 cart is designed to withstand defibrillation and will recover within 5 seconds (per IEC 60601-1, Requirements for the Safety of Medical Electrical Equipment, and IEC 60601-2-49, Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment). Positioning the MR400 During use, station the cart at a safe monitoring distance in the MR magnet room then press down on each wheel lock to engage it. (When the cart needs to be moved, raise each wheel lock before proceeding). Use the guide handle to move and position the MR400. Always place the MR400 so that your view of the screen and alarm light will remain unobstructed during use. CAUTION Never lean against or apply excessive force to the guide handle. 3‐2 Getting Started Expression MR400 Instructions for Use When positioning the MR400 for use, observe the following warning and cautions: WARNING Warning .The MR400 shall meet its full function and performance specifications when positioned in the MR room of a 3T magnet, up to the 5000 gauss line, 4W/kg SAR, and 7.2 µT B1rms in all orientations. Always secure the MR400’s wheel locks when the unit is placed within the MR system room. Failure to properly position the MR400 and its accessories in the MR system room will result in system or accessory failure, and possible patient or user injury. CAUTIONS • If the MR400 rolls to the face of the MR system due to magnetically induced pull force, do not attempt to dislodge the MR400 by pulling from the display panel or guide handle; instead, dislodge the MR400 by gently pulling from the lowest point of the base. This will prevent the base of the unit from experiencing higher MR pull forces in the vertical direction. • Position the MR400 in a manner which does not block access to the device or wall plug connectors. • Field strength variations in a particular MR system room (which may be due to active shielding technology, manufacturer variability, future enhancements, etc.) can make distinguishing the 5,000 gauss level (as measured from the center line of the MR bore) difficult. These variations may require moving the MR400 away from the MR system if system abnormalities or malfunctions are observed. Prior to clinical use, ensure that the allowable distance of the MR400 from the MR system is maintained for proper operation. Operating the MR400 SAFETY AWARENESS WARNING Warning Do not start up the product unless you and all other users present have read, fully understood and know all the safety information and emergency procedures given in the Safety section of this Instructions for Use. Operation of the product without having read, understood and knowing ALL the safety information and procedures in the SAFETY section could lead to fatal or other serious personal injury. It could also lead to clinical mis-diagnosis or clinical mistreatment. Expression MR400 Instructions for Use Getting Started 3‐3 Follow the steps below when operating the MR400. Step Action Press the power switch ; see page 2‐7 for the location. Ensure that the wECG and wSpO2 modules (and IP5, if equipped) have established good communications, and that sufficient power exists for the MR400 and the wireless modules. Also verify proper operation of the patient parameters. See System Power‐up and Communications Verification, below. System Power-up and Communications Verification WARNING Warning Always perform operational verification prior to use and during monitoring by ensuring proper communications between the MR400, the wireless modules and IP5 (if equipped). Failure to ensure proper communications can result in the loss of patient monitoring and the loss of data transfer in networked systems equipped with an IP5. If a device fails to function properly, remove it from use and contact technical support. The MR400 reaches an operational state within 60 seconds after power‐up and attains full measurement accuracy according to the equipped options: • After approximately 2 minutes when equipped with the CO2 LoFlo option • After approximately 10 minutes if equipped with the AGENT option. When any displayed warm‐up message disappears, the MR400 is ready for use. To apply power to the MR400 and verify system communications Step Action Ensure that batteries are installed in the wECG module (see page 1‐ 24). Check the battery indicators on the wECG module to ensure that enough charge exists in at least one of the installed batteries: • Green battery indicator = Charge sufficient; proceed to step 4. • Red battery indicator = Charge low; proceed to step 3. See page 2‐9 for details. (Also, you can reference the status information pane; see page 2‐16.) 3‐4 Getting Started According to the red battery indicator(s) present on the wECG module, insert a charged module battery into the corresponding battery bay(s) and then recheck the battery indicator(s) to ensure a sufficient charge before proceeding; see page 1‐24. Expression MR400 Instructions for Use Step Action Ensure that batteries are installed in the wSpO2 module (see page 1‐26). Check the battery indicator on the wSpO2 module to ensure that enough charge exists: • Green battery indicator = Charge sufficient; proceed to step 7. • Red battery indicator = Charge low; proceed to step 6. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Insert a charged module battery into the wSpO2 module and then recheck the battery indicator to ensure a sufficient charge before proceeding; see page 1‐26. With the cart batteries installed and with the MR400 connected to AC mains power (see page 1‐20), press the power switch. Allow the MR400 to initialize. (Optional) If equipped, turn on the IP5. Check the network channel indicator on the wECG module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 11. • Flashing = No communication; proceed to step 10. See page 2‐9 for details. (Also, you can reference the status information pane; see page 2‐16.) An inoperative ECG parameter or wECG module is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm. 10 Ensure that the wECG module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. 11 Check the network channel indicator on the wSpO2 module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 13. • Flashing = No communication; proceed to step 12. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Expression MR400 Instructions for Use 12 Ensure that the wSpO2 module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. 13 (Optional) If equipped with an IP5, ensure that the wireless network channel of the IP5 is the same as the wireless network channel setting of the MR400; see the IP5 IFU for details. Getting Started 3‐5 Step Action 14 (Optional) If equipped with an IP5, ensure good communication between the MR400 and the IP5 by checking the status information pane (see page 2‐16). 15 Ensure proper operation of each patient parameter and alarms. Refer to appropriate chapters in this manual. CAUTION If power to the wireless device with established communications is lost or removed, its network connection will be dropped. Cart Power-down To turn power off to the MR400, press then hold the power switch for approximately 2 seconds. NOTE For instructions on the complete removal of power to the MR400, see page 14-2. Wireless Module Power-down To turn power off to a wireless module, remove the battery (wSpO2 module) or batteries (wECG module). Monitor Initialization After power‐up and until the initialization process completes, the touch screen may remain blank. After initialization completes, the MR400 can begin monitoring functions from an initial factory default state or from a pre‐configured state, depending upon the way the stored configurations and patient data are programmed for startup. Visually checking the patient and confirming changing measurements against other vital signs should be standard routines during use. 3‐6 Getting Started Expression MR400 Instructions for Use WARNING Warning When using an IP5, make sure that the content of the User Settings option matches that of the MR400 option, and that the same option is selected as the default setup on both systems (see page 3-26). This is important because the device first booted will determine the poweron settings of the system (that is, the MR400 and optional IP5). Viewing the Displayed Information The high resolution touch screen LCD facilitates waveform analysis and vital sign numeric interpretation, with important display elements which are designed to be legible at a minimum distance of 1 meter by users with a visual acuity of 20/20. When using the MR400, always adjust the viewing angle of the touch screen to complement your line of sight and always ensure that your view remains unobstructed. CAUTION Never apply unnecessary force to the touch screen as it can result in damage or failure. NOTE To change the language displayed by the MR400, see System Config page 3-30. Default Settings At power up, the MR400 will automatically set all monitor setup options as determined by the default selection in the Edit User Settings menu. By default, the factory settings are used when the system is turned on, unless a custom setting has been selected. Also, as discussed earlier, due to the use model, the power‐on default settings for the MR400 can depend upon a communicating IP5 and the start‐up sequence of the devices. Default Setting Indications The User Settings key indicates the current default setup (where the plus symbol [+] indicates that changes have occurred) and it allows you to select a factory or a stored user setup; see page 2‐14. When a menu is displayed, the default will be highlighted or will appear with an asterisk. For the factory default settings, see the menu listings throughout this IFU. Expression MR400 Instructions for Use Getting Started 3‐7 User Settings In the Edit User Settings menu, up to ten customized user settings can be saved and one can be selected for use as the default at power‐on. User settings can include any of the following menu options: 3‐8 Getting Started • Alarms – Minimum and maximum values – Auto‐set percentage – Alarm sound level – Extreme HR alarm values – Desat alarm values • System Setups • ECG – – – – – – – – Selected lead Scale setting Trace speed Filter mode QRS tone on/off Heart rate source Pediatric ECG on/off Extreme HR alarm function setting • SpO2 – Size – Desat alarm function settings • CO2 – Size – Grids • CO2 (RESP) – Apnea alarm function settings • NIBP – Manual – Off or Auto – Automatic time interval • Trend graphs – Time bases – Scales • Print Setups – Off or Auto – Trace delay – Printer speed – Selected traces Expression MR400 Instructions for Use NOTE When a setting is changed in an active user settings file, a plus sign (+) will appear on the User Settings key. And when edits have been made to an existing user settings file, a warning box and setting change list will appear, prompting you to accept or cancel the changes to proceed. Soft Keyboard—Add New Names can be assigned to your user settings files using the soft keyboard that is displayed when the Add New option is selected; see page 3‐15. This soft keyboard (see illustration below) functions like standard QWERTY keyboard, but with additional features for data captures and default setting selection. Save & Close button assigns the captured settings to the entered file name then saves the file in memory and closes the menu. Capture Settings button saves the current settings data of the MR400. Set To Default button selects the settings of the current entry for use following power-up of the MR400. Entry field displays the currently entered file name for the captured user settings. Soft Keyboard—Edit Existing Existing user settings files can be edited using the soft keyboard that is displayed when a stored file is selected; see page 3‐15. The file name and data contents can be changed, and the default setting can be updated. The illustration below highlights these additional file management features of the soft keyboard. Expression MR400 Instructions for Use Getting Started 3‐9 2 Remove as Default button removes the file as the default user settings file Delete Settings button deletes the file. Initial Alarm Indications After power‐up and immediately following the recall of a stored setup, the MR400 provides an indication of the alarm volume by sounding the alarm tone at its currently adjusted setting for 5 seconds and displaying Check Alarm Volume. After power‐up, the initial alarm state is paused and then, following a wait period of 120 seconds, armed becomes the normal alarm state (as indicated by the displayed symbol, shown in the table below): Displayed Symbol Alarm Sound State Alarm audio armed Alarm audio paused Alarm audio off In the armed state: • 3‐10 Getting Started An alarm will sound while an alarm condition exists, provided that any pre‐alarm wait period has expired and the alarm audio armed symbol is displayed. Expression MR400 Instructions for Use • Alarm flags related to other alarm sound states will be removed from the display. • An alarm condition not previously placed in an audio off state will cause the alarm to sound. Selecting the Patient Type Determining the Patient Type IEC 80601‐2‐30 Edition 1.0, the international standard regarding particular requirements for safety, including essential performance of automatic cycling non‐invasive blood pressure monitoring equipment, defines patient types in two categories: neonatal and adult. Neonatal patients are defined by the approximate age range of birth to a few weeks. All other patients are identified as adults. ANSI/AAMI SP10:2008, the American National Standard for manual, electronic, or automated sphygmomanometers, defines patient types according to age limitations, as indicated in the table below. Patient Type Neonatal Pediatric Adult Age Birth to 28 days 29 days to 12 years Greater than 12 years Similarly, the Food & Drug Administration defines patients within two categories: pediatrics and adults. Each category is further defined into subgroups according to approximate age. Patient Type Subgroup Approximate Age Range Pediatric Newborn (neonate) Birth to 1 month Pediatric Infant Greater than 1 month to 2 years Pediatric Child Greater than 2 to 12 years Pediatric Adolescent Greater than 12 to 21 years Adult --- Greater than 21 years CAUTION There may be occasions when a particular mode is not suitable for its apparent category of patients based on age alone. In these cases, a clinical decision shall be made to use another patient type or measurement technique. The clinical decision shall be based on all of the factors listed in Determining the Patient Type (above) to ensure the best possible and most timely measurement acquisitions. Expression MR400 Instructions for Use Getting Started 3‐11 Regardless of the definition, each agency recognizes that the patient type descriptions can be arbitrary and that the following patient factors are more accurate in determining the appropriate method of patient monitoring and treatment: – Weight – Body size – Limb circumference – Physiological development – Neurological development – Neuromuscular coordination Accordingly, the MR400 uses several operational parameters, including cuff inflation pressure and pulse sensitivity, that vary depending on the selected patient type. (Always refer to information about the corresponding parameter for other possible considerations when determining the patient type.) The Patient Type key allows you to set the MR400 for the type of patient to be monitored. To open the Patient Type menu Press the Patient Type key. Patient Type key Patient Type menu The following patient types are available: 3‐12 Getting Started • Adult (Default) • Pediatric Expression MR400 Instructions for Use • Neo (when selected, Pediatric ECG will also be set to On) NOTE Changing the Patient Type causes the alarm to sound, Change NIBP Cuff to be displayed for 30 seconds, the initial cuff inflation to be reset to the initial pressure for the patient type selected, NIBP > Auto Mode to be set to off, and the alarm limit settings to revert to the default values24). To select the patient type Step Action Press the Patient Type key. (The current setting is displayed.) The Patient Type menu appears. The current setting is highlighted. Select the Patient Type: Adult Pediatric Neo The setting is entered. Setup Menus Pressing the Setup key will display the Monitor, Printer, and Alarms keys. Setup key Monitor key Printer key Alarms key The Monitor, Printer, and Alarms keys open associated menus for setup and control, including: • Saving and recalling setup configurations • Controlling parameters • Adjusting sounds • Switching patient types • Setting time and date Expression MR400 Instructions for Use Getting Started 3‐13 • Setting sweep speeds • Controlling ECG modes • Controlling alarms • Controlling remote printing WARNING Warning When using an IP5, wait at least 4 seconds if performing a recall or setting a parameter value, as these require a few seconds to propagate through the system. Performing another recall within 4 seconds of a previous recall or after a value change, may result in improperly recalled data. NOTE Grayed out items in the menu system, indicate features or options that are inaccessible due to current settings, or that are not configured or installed. Monitor Setup Menu The Monitor Setup menu allows you to configure the MR400 for patient monitoring. To open the Monitor Setup menu Press the Setup key and then the Monitor key. Monitor Setup menu Setup key Monitor key 3‐14 Getting Started Expression MR400 Instructions for Use The following Monitor Setup menu items are available: • Edit User Settings • Parameters • Sound Adjust • Set Time & Date • Sweep Speed • Resp Speed • Service(Bio-Med) To change settings in the Monitor Setup menu Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. Select any of the following menu items: Edit User Settings Parameters Sound Adjust Set Time & Date Sweep Speed Resp Speed Service(Bio‐Med) The selected menu appears. Current settings are displayed. Select the desired menu item. The current setting is highlighted. Select the desired sub‐menu or setting from the menu options. The setting is entered. To change other settings, repeat steps 2, 3 and 4. Edit User Settings Allows you to capture, store and manage multiple user setups, and to select an operational or power‐up default setup. A backup and restore selection also allows you to save these user settings to an external device. To open the Edit User Settings menu Expression MR400 Instructions for Use Getting Started 3‐15 Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Edit User Settings. Factory Add New Backup/Restore The following options are available: • Factory recalls the factory settings from memory, which cannot be modified. (Default) • Add New allows you to assign a file name, select a default setting, and store a current setup in the memory (up to ten setups can be stored); see page 3‐7 for more information. • Backup/Restore allows you to backup and restore settings using a USB flash drive; see the service manual (REF 989803181911) for details. To add and save new user settings Step Action Setup the MR400 for the configuration to which these settings will pertain. Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Edit User Settings. The Edit User Settings menu appears. Select Add New. The soft keyboard appears. 3‐16 Getting Started Enter a unique file name (of up to twenty characters) for the user settings using the soft keyboard. Press the Capture Settings button to enter the current setup data. Expression MR400 Instructions for Use Step Action If desired, press the Set to Default button to save the current file as the default setup for use at power‐up. WARNING Warning If you choose to boot the device from a user settings file, confirm that alarm presets are appropriate for the patient prior to monitoring. Failure to do so may cause false or missed alarm conditions. Press the Save & Close button to save the current setup and exit the menu. A warning box will appear, prompting you to accept the changes: press the Accept button to save the current settings, or press the Cancel button to reject the changes. To edit saved user settings Step Action Configure the MR400 for the desired settings. On the Monitor Setup menu, select Edit User Settings. Select the file name that you want to change. Press the Capture Settings button to change the user setup to the current settings. Press the Save & Close button to save the current setup. A warning box will appear, prompting you to accept the changes— press Accept to save the current settings or press Cancel to reject the changes. To delete saved user settings Step Expression MR400 Instructions for Use Action On the Monitor Setup menu, select Edit User Settings. Select the file name that you want delete. Getting Started 3‐17 Step Action Press the Delete Settings key. Press the Save & Close button to save the current setup. A warning box will appear, prompting you to accept the changes— press Accept to save the current settings or press Cancel to reject the changes. Parameters Controls monitoring functions, as indicated by the absence or presence of the VS box for the parameter, except ECG (see below). NOTE Some parameters require optional equipment that may not be enabled or present on your system; see System Config for details. To open the Parameters menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Parameters. ECG NIBP P1 P2 SPO2 CO2 RESP TEMP AGENT The following parameters are available: • ECG allows electrocardiogram monitoring: – Off turns off the ECG parameter. (Heart rate (HR) will remain in the VS box, allowing it to be displayed from another source or if HR Source is set to Auto.) 3‐18 Getting Started Expression MR400 Instructions for Use – On turns on the ECG parameter. (Default) • NIBP allows non‐invasive blood pressure monitoring (does not have an associated waveform): – Off turns off the NIBP parameter. – On turns on the NIBP parameter. (Default) • P1 allows invasive blood pressure monitoring: – Off turns off the P1 parameter. (Default) – On turns on the P1 parameter. • P2 allows invasive blood pressure monitoring: – Off turns off the P2 parameter. (Default) – On turns on the P2 parameter. • SPO2 allows oxygen saturation of arterial blood monitoring: – Off turns off the SPO2 parameter. – On turns on the SPO2 parameter. (Default) • CO2 allows CO2 and CO2‐derived respiration rate monitoring: – Off turns off the CO2 parameter. (Default) – On turns on the CO2 parameter. NOTE If CO2 is turned Off, AGENT and GAS will also be deactivated. • RESP allows respiration rate monitoring using the bellows (does not have an associated waveform): – Off turns off the bellows‐derived respiration parameter. (Default) – On turns on the bellows‐derived respiration parameter. NOTE If CO2-derived respiration is on, then RESP will not be selectable. To use bellows respiration, select BEL in the RESP menu; see page 10-5. • TEMP allows temperature monitoring (does not have an associated waveform): – Off turns off the temperature parameter. (Default) – On turns on the temperature parameter. Expression MR400 Instructions for Use Getting Started 3‐19 • AGENT allows anesthetic agent and gas monitoring (but does not have an associated waveform), and CO2 and CO2‐derived respiration rate monitoring: – Off turns off the AGENT parameter. (Default) – On turns on the AGENT parameter. NOTE When AGENT is turned on, CO2 will also be activated, including GAS; however, if AGENT is then turned Off, CO2 will remain active. To control parameters Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Parameters. The Parameters menu appears. Current settings are displayed. Locate the parameter that you want to control then select the desired setting: Off On The setting is entered. To change other settings, repeat step 3. Sound Adjust Controls alarm, heart rate and touch screen tones, and the volume settings for the sounds generated by the MR400. WARNING Warning The alarm sound can be turned off, as indicated by the symbol. Always ensure that the alarm sound setting is appropriate for the monitoring environment and for each patient. The alarm sound volume is adjustable for suitability to various clinical environments. When you use the MR400, always ensure that the alarm sound can be heard above the ambient noise level; otherwise, treatment of the patient could be delayed. To open the Sound Adjust menu 3‐20 Getting Started Expression MR400 Instructions for Use Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Sound Adjust. Alarms HR Tone Source Alarm Volume Pulse Volume Click Tone Click Volume The following menu items are available: • Alarms controls the alarm sound (identical to and interactive with Alarm Sound in the Alarms menu): – Off turns off the alarm sound, as indicated by the alarm audio off symbol (see page 4‐ 4). (Only the alarm sound will be disabled; visual alarm indications will continue.) – On turns on the alarm sound, as indicated by the alarm audio armed symbol (see page 4‐4). (Default) • HR Tone Source sets the source used for the heart rate tone (identical to and interactive with same option in the ECG menu and SPO2 menu): – Off removes the heartbeat detected symbol from the display and sounds no pulse tone. (Default) – QRS provides the heartbeat detected symbol and a tone triggered by the QRS detection from the ECG vital sign. – SPO2 provides the heartbeat detected symbol and a tone modulated by the SPO2 vital sign, where the lower the SPO2 value, the lower the pitch. • Alarm Volume sets the alarm sound level from 1–10. (Default = 4) • Pulse Volume sets the pulse sound level from 1–10. (Default = 4) • Click Tone controls an audio indication that is produced when an active area of the touch screen is contacted: – Off does not produce a click tone. – On produces a click tone. (Default) • Click Volume sets the click tone sound level from 1–10. (Default = 4) Expression MR400 Instructions for Use Getting Started 3‐21 To control the sounds Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Sound Adjust. The Sound Adjust menu appears. Current settings are displayed. Select the menu item for the sound function that you want to control: Alarms HR Tone Source Alarm Volume Pulse Volume Click Tone Click Volume The menu item appears. The current setting is highlighted. Select the desired setting from the menu options (except Alarms and Click Tone, which are selectable on the Sound Adjust menu.) The setting is entered. NOTE When making adjustments to the volume settings, Real Tones Disabled will be displayed and a momentary sound at the setting level will be produced. To your save changes and close the menu select . To change other settings, repeat steps 3 and 4. Set Time & Date Sets the time and date, and the displayed time and date formats; see page 2‐14. To open the Set Time & Date menu 3‐22 Getting Started Expression MR400 Instructions for Use Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Set Time & Date. IPx Time Sync Time Format Date Format Second Minute Hour Day Month Year The following menu items are available: • IPx Time Sync synchronizes the time and date settings of the MR400 to that of an IP5 (IP5 option required). • Time Format changes the format of the displayed (and printed) hours:minutes:seconds (hh:mm:ss): – 12 Hr uses the 12‐hour (hh) convention (01 – 12) with the AM or PM designation. – 24 Hr uses the 24‐hour (hh) convention (00 – 23). (Default) • Date Format changes the format of the displayed (and printed) date: – Month/Day/Year: Uses a/ / format – Day/Month/Year: Uses a / / format – Month Day, Year: Uses a , format • Second scrolls the second counter. • Minute scrolls the minute counter. • Hour scrolls the hour counter. • Day scrolls the day counter. • Month scrolls the month counter. • Year scrolls the year counter. To set the format of the displayed time or date Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. Expression MR400 Instructions for Use Getting Started 3‐23 Step Action On the Monitor Setup menu, select Time and Date. The Time and Date menu appears. Current settings are displayed. Select the menu item for the time or date function that you want to change: Time Format Date Format The menu item appears. The current setting is highlighted. Select the desired setting from the menu options. The setting is entered. To change other settings, repeat steps 3 and 4. To set the time or date Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Time and Date. The Time and Date menu appears. Current settings are displayed. Use the arrow keys associated with each time or date function that you want to change (left arrow decreases the setting, right arrow increases the setting): Second Minute Hour Day Month Year The setting is changed. To adjust other settings, repeat step 3. When finished, select the check mark The changes are saved and the displayed time is adjusted. 3‐24 Getting Started Expression MR400 Instructions for Use Sweep Speed Sets the sweep rate for all waveforms (displayed and printed), except CO2. To open the Sweep Speed menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Sweep Speed. 50 mm/s 25 mm/s The following speeds (in millimeters per second) are available: • 50 mm/s • 25 mm/s (Default) To adjust the sweep rate for all waveforms (except CO2) Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Sweep Speed. The Sweep Speed menu appears. The current setting is highlighted. Select the desired setting from the menu options: 50 mm/s 25 mm/s The setting is entered. Resp Speed Sets the sweep rate for the CO2 waveform. To open the Resp Speed menu Expression MR400 Instructions for Use Getting Started 3‐25 Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Resp Speed. 25 mm/s 12.5 mm/s 6.25 mm/s 3.125 mm/s The following speeds (in millimeters per second) are available: • 25 mm/s • 12.5 mm/s (Default) • 6.25 mm/s • 3.125 mm/s To adjust the sweep rate for the CO2waveform Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Resp Speed. The Resp Speed menu appears. The current setting is highlighted. Select the desired setting from the menu options: 25 mm/s 12.5 mm/s 6.25 mm/s 3.125 mm/s The setting is entered. Service(Bio-Med) Accesses a sub‐menu that contains software and firmware information about the system, and options for NIBP and P1 (and P2) pressures, diagnostics and configuration. To open the Service(Bio‐Med) menu 3‐26 Getting Started Expression MR400 Instructions for Use Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). Revision Information Simulation Mode Gas Cal System Config ECG Tests NIBP Tests Backlight Brightness Service Utilities NOTE Some menu items require entry of a password for access; see page 2-23. To access the SERVICE(BIO‐MED) menu items Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) sub‐menu appears. Select the desired menu item (some menus are password protected): Revision Information Simulation Mode Gas Cal System Config ECG Tests NIBP Tests Backlight Brightness Service Utilities The selection is entered (or enter the correct password for access). Select the desired menu or item, except Simulation Mode, which is selectable on the Service(Bio‐Med) menu. The setting is entered. Expression MR400 Instructions for Use Getting Started 3‐27 Step Action To change other settings, repeat steps 2, 3 and 4. Revision Information Depending upon the installed options, displays revision information for the software and firmware used in the MR400 and wireless modules. To view the revision information Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select Revision Information. WECG SW: WECG SW CHKSUM: WECG FW: IOP SW: FPGA FW: Cart SW: TEMP FW: GAS FW: PICO NIBP SW: The definitions for the items displayed in Revision Information are provided below. 3‐28 Getting Started Name Definition WECG SW Software revision of the wECG module WECG SW CHKSUM Checksum of the software of the wECG module WECG FW Firmware revision of the wECG module IOP SW Software revision of the input / output processor FPGA FW Software revision of the processing element of the MR400 Cart SW Software revision of the MR400 cart TEMP FW Firmware revision of TEMP system GAS SW Software revision of gas system PICO NIBP SW Software revision of the NIBP system Expression MR400 Instructions for Use Simulation Mode WARNING Warning The MR400 is equipped with a simulation mode that displays computer generated data for training or demonstration. As a safety feature, Simulation is displayed and appears on all printouts while in simulation mode. Do not attach a patient to the MR400 when in simulation mode and never activate simulation mode when a patient is connected. The MR400 will not monitor patients while in the simulation mode. Activating simulation mode when a patient is connected will result in a lapse in patient monitoring and could result in a delay in treatment. Allows the MR400 to operate using internally‐ generated data instead of patient data. To open the Simulation Mode menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, locate Simulation Mode and select On. Enter the password. The following controls are available: • Off displays normal monitoring functions. (Default) • On displays simulations of monitoring functions. To enter simulation mode Step Action Ensure that no patient is connected to the MR400. Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) menu appears. Current settings are displayed. Locate Simulation Mode and select On. When Enter Password is displayed, enter the correct six‐digit code. Simulation will be displayed in the system message area of the simulated screen. To exit simulation mode, turn off the power switch. Expression MR400 Instructions for Use Getting Started 3‐29 Gas Cal Calibrates the gas function(s) when equipped with the CO2 or the AGENT option. NOTE As indicated by displayed message, allow any warm-up to complete before calibrating. To open the Gas Cal menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select Gas Cal. Zero Cal O2 Cal CO2 Accuracy Check The following menu items are available: • Zero Cal Initiates a zero calibration (a function that occurs automatically during normal use). For LoFlo CO2 option details, see page 7‐2; and for the AGENT option details, see page 9‐2. • O2 Cal performs a 1‐minute pressure calibration of the O2 sensor for the AGENT option. Connection of a sample line is required for this test. • CO2 Accuracy Check tests the LoFlo CO2 accuracy (a 5% gas source must be connected to the MR400). Provides a CO2 waveform value (as a percentage), an atmospheric pressure reading and a numeric CO2 value (in mmHg). NOTE During the CO2 Accuracy Check, to alert you that the indicated values are not actual patient measurements, the following message will be displayed: CO2 test in progress. Do not use CO2 values for patient monitoring during test. Pressing close will cancel test. System Config Controls the configuration of the MR400 including options, language and unit of measurement for pressures. 3‐30 Getting Started Expression MR400 Instructions for Use To open the System Config menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select System Config. ECG 1 ECG 2 NIBP P1 P2 SPO2 Gas Bench RESP TEMP 10 Language 11 ECG Notch Filter 12 Pressure Units 13 Gas Units 10 11 12 13 The following menu items are available: • ECG 1 configures the MR400 for ECG 1 • ECG 2 configures the MR400 for ECG 2 • NIBP configures the MR400 for NIBP • P1 configures the MR400 for P1 • P2 configures the MR400 for P2 • SPO2 configures the MR400 for SPO2 • Gas Bench configures the MR400 for the gas bench option, where CO2 only selects the CO2 Loflo option, Agents selects the AGENT option • RESP sets the configuration of the unit for bellows‐derived RESP • TEMP configures the MR400 for TEMP • Language sets the language for the displayed information: – English (Default) – Deutsch – Espanol – Francais Expression MR400 Instructions for Use Getting Started 3‐31 – Portuguese – Italiano – Dansk – Svenska – Norsk – NLD • ECG Notch Filter applies a notch filter to the ECG signal: – Off – 50Hz – 60Hz (Default) • Pressure Units sets the unit of measure for P1, P2, and NIBP pressure readings: – mmHg (Default) – kPa • Gas Units sets the unit of measure for CO2 pressure readings: – mmHg (Default) – kPa ECG Tests Accesses testing functions for ECG. To open the ECG Tests menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select ECG Tests. ECG Signal Test The following menu items are available: • ECG Test Signal controls a wECG module‐generated 1 mV peak‐ to‐peak square wave, where 60 BPM will be displayed in the ECG VS box and ECG Test Signal will be displayed in the alarm flag area (and printed when output to the printer, if equipped): – Off does not transmit the test signal. (Default) – On transmits the test signal. 3‐32 Getting Started Expression MR400 Instructions for Use NOTE ECG Test Signal is unavailable when Filter Mode > Advanced 2 is selected; see 5-31. To control the ECG Test Signal Step Action Ensure that the wECG module is communicating with the MR400. Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) menu appears. Current settings are displayed. Locate ECG Test Signal and select the desired setting: Off On The setting is entered. NIBP Tests Accesses calibration and testing functions for NIBP. NOTE If Module Not Calibrated is displayed, then all options in the NIBP Tests menu will be locked until NIBP is successfully calibrated. To open the NIBP Tests menu Expression MR400 Instructions for Use Getting Started 3‐33 Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select NIBP Tests. Calibrate Static Test Leak Test Stress Test High Range Check The following menu items are available: • Calibrate performs calibration of the NIBP system. (Password required) • Static Test performs a static pressure test of the NIBP system. (Password required) • Leak Test performs a pressure leak test of the NIBP system (see note below). • Stress Test performs a pressure stress test of the NIBP system. (Password required) • High Range Check performs a high pressure test of the NIBP system. (Password required) NOTE If an error is reported while the Leak Test is in progress, the test will be canceled and user will be prompted with the message: NIBP Bench Error. Press Start to try again. To perform these tests See reference the service manual for details. Backlight Brightness Adjusts the brightness of the touch screen. To open the Backlight Brightness menu 3‐34 Getting Started Expression MR400 Instructions for Use Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select Backlight Brightness. The following brightness levels are available: • 1 (Minimum) • • • • • 6 (Default) • • 8 (Maximum) To control the brightness of the display backlight Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) menu appears. Current settings are displayed. Select Backlight Brightness and then enter the desired brightness level: 1–8 The setting is entered. Service Utilities Accesses service‐related functions (a password is required for access). To open the Service Utilities option Expression MR400 Instructions for Use Getting Started 3‐35 Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select Service Utilities. Enter the password. NIBP Diagnostics CO2 Diagnostics Radio Diagnostics The following menu items are available: 3‐36 Getting Started • NIBP Diagnostics opens a window that displays NIBP diagnostic data. • CO2 Diagnostics opens a window that displays CO2 diagnostic data. Expression MR400 Instructions for Use • Radio Diagnostics opens a window that displays radio diagnostic data. Expression MR400 Instructions for Use Getting Started 3‐37 3‐38 Getting Started Expression MR400 Instructions for Use CHAPTER 4 Alarms The alarm information here applies to all measurements. Measurement‐specific alarm information is discussed in the sections on individual measurements. The monitor provides patient alarms and INOP alarms. Patient Alarms Patient alarms will illuminate a red or yellow alarm light, where a red alarm light indicates a high priority alarm to alert you to potentially life threatening situations for your patient (for example, a disconnected catheter). A yellow alarm light indicates a lower priority patient alarm (for example, a respiration alarm limit violation). Patient alarms may also generate flashing numeric values or other indications, alarm flags and sound an audible alarm (provided that a higher priority alarm sound does not override it). For example, if a patient’s heart rate climbs to 71 BPM (which is above the setting of the upper alarm limit) a physiological alarm condition is declared. Medium priority alarm example (ECG heart rate value) Violated (high) alarm limit setting INOPs INOPs are status and technical alarms—they indicate that the monitor cannot measure or detect alarm conditions reliably; see page 4‐31 for a listing. Depending upon the nature of the condition detected, INOPs will illuminate the alarm light, generate an alarm flag, and sound an audible indicator tone (provided that a higher priority alarm sound does not override it). Other status and technical alarms have a medium or high priority depending upon the nature of the condition detected. Multiple Alarms Patient alarms are mutually exclusive and the highest priority alarm will be indicated by the alarm light; if a high priority alarm and a medium priority alarm are present simultaneously. the red alarm light will be on, but the yellow alarm light will not be. Expression MR400 Instructions for Use Alarms 4‐1 The blue alarm light can be on at the same time as the red or yellow alarm light. When a numeric value becomes missing due to an INOP, the INOP alarm will be present as well as the patient alarm (due to the missing value), with both originating from the same cause. Alarm Delays There is an alarm sound and an alarm light illumination delay of no more than 4 seconds following the displayed alarm flag, provided that the alarm condition still exists after this delay. Alarm Safety Information WARNINGS • The monitor detects and responds almost immediately to most out-of-limits conditions, except when averaging of the physiological signal is required to reduce unwanted noise signals (for example, respiration rates and measurements derived from SpO2 signals.) • Set the alarm volume based upon the ambient noise levels in the MR environment. Some areas in the MR environment, such as the MR system room, may have ambient noise levels louder than the maximum volume of the MR400. Therefore, displayed data should be continuously monitored. Otherwise, if sound was inaudible, treatment of the patient could be delayed. For visual alarms, adjust the position of the MR400 so that you maintain a clear view of the display. Visual Alarm Indications Depending upon the alarm condition, visual alarm indications can include an alarm flag, a flashing numeric, and an illuminated alarm light; when multiple alarms are detected, multiple visual indications may be presented. Alarm Flags Alarm flags are visual indicators that contain an alarm message displayed on a background color that identifies the priority of the alarm (see table below). An alarm flag is displayed for the duration of an alarm condition. Multiple alarm flags are displayed when multiple alarm conditions exist. 4‐2 Alarms Alarm Priority Displayed Background Color High (patient alarm) Red Medium (patient alarm) Yellow INOP (status or technical alarm) Blue Expression MR400 Instructions for Use Alarm flags associated with a vital sign are displayed alongside the VS box of that parameter (see illustration below), while alarm flags associated with the system are displayed in the system message area (middle and top center of the touch screen, see page 2‐21). When multiple alarm flags are present, they will be stacked in a column. Alarm flag (an INOP in this example) Flashing Numeric During an patient alarm condition, the vital sign numeric will change color and flash to indicate the source, type and priority of the alarm: • High priority patient alarm—red numeric, flashing at 1.5 Hz with a 50% duty cycle. • Medium priority patient alarm—yellow numeric, flashing at 0.75 Hz with a 50% duty cycle. While the violation continues, the numeric of the violated parameter will flash in priority color of the detected alarm. Alarm Light During an alarm condition, the alarm light (see inset) can illuminate to provide a 360 degree, visual indication of the alarm priority, as detailed in the table below. Multiple colors can be illuminated when multiple alarm conditions exist. The alarm light is a menu‐controlled feature; see page 4‐20 for setting details. Alarm light, red or yellow Alarm light, blue Speaker Display panel Alarm Priority Light Color Indication High (patient alarm) Red Flashing, 1.5 Hz with a 50% duty cycle Medium (patient alarm) Yellow Flashing, 0.75 Hz with a 50% duty cycle INOP (status or technical alarm) Blue Steady Expression MR400 Instructions for Use Alarms 4‐3 Audible Alarm Indications WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Depending upon the severity and type of the alarm condition, alarm priority tones with distinct pitches are sounded by the speaker (see illustration on page 4‐3). When multiple alarms are detected, the highest priority alarm is announced. Alarm priority Fixed Pitch Mnemonic Notes High c c c – c c Medium c c c INOP e c Once activated, an audible alarm indication continues as long as the alarm condition is present or until you acknowledge the alarm by pressing the Audio Pause key or the Alarm key (or by placing the MR400 in suspend mode). Alarm Sound State Indication Depending upon the current setting, one of three possible symbols are provided to indicate the alarm sound state, which is displayed at all times in the information bar (see page 2‐14). Symbol definitions for the alarm sound state are provided in the table below. Displayed Symbol Alarm Sound State Alarm audio armed Alarm audio paused Alarm audio off 4‐4 Alarms Expression MR400 Instructions for Use Initial Audible Alarm Setting Indications After power‐up and immediately following the recall of a stored setup, the MR400 provides an indication of the alarm volume by sounding the alarm tone at its currently adjusted setting for 5 seconds and by displaying Check Alarm Volume. Audio paused is the initial alarm state and then, following a wait period of 120 seconds, armed becomes the normal alarm state, where: • An alarm will sound while an alarm condition exists, provided that any pre‐alarm sound delay has expired and that the alarm audio armed symbol is displayed. • Alarm flags related to other alarm sound states will be removed from the display. • An alarm condition not previously placed in an alarm audio off state will cause the alarm to sound. Controlling the Alarm Audio and Light Indications Alarm audio indications and the alarm light can be controlled to meet the desired level of response using the Audio Pause key or the Alarm key. Note When an alarm is indicated, always confirm the alarm conditions with clinical observations of the patient before administering interventions. Failure to do so may result in inappropriate intervention. Expression MR400 Instructions for Use Audio Pause key Alarm key Alarms 4‐5 Audio Pause Mode Audio pause mode can is useful to temporarily silence alarms and to temporarily extinguish the alarm light (for example, when changing ECG leads or during other user activities that might cause a “false” alarm). Audio pause mode is indicated when the Audio Paused alarm flag, the audio paused symbol (see page 4‐4) and a countdown timer are displayed. (The 120‐second countdown timer period is not user adjustable.) During this period, the audible alarm will be suspended for any new alarm conditions that occur. Any messages related to other alarm sound states will be removed. To activate Audio Pause Press the Audio Pause key: • If the alarm is not sounding, press the key once. • If the alarm is sounding, press the key twice. To deactivate Audio Pause • Wait until the 120‐second countdown reaches zero (0), or • Press the Audio Pause key. Audio Off Mode In audio off mode, the alarm tone will cease, the alarm light will be extinguished, and the Audio Off message and the audio off symbol (see page 4‐4) will be displayed. Any new alarm condition will cause audio off mode to be exited and the alarm tone to be sounded. However, a current alarm condition previously silenced will not sound again unless the condition returns within limits and then violates a limit again. Audio off mode allows you to disable the alarm tone and alarm light during an alarm condition, while allowing new alarm conditions to reactivate all alarm functions. While the violation continues, the numeric of the violated parameter will flash in priority color of the detected alarm. WARNING An active silenced alarm may not be accompanied by the Audio Off message and symbol , if Audio Paused has been activated, or if a subsequent additional alarm has occurred and was self-corrected. To activate Audio Off Press the Alarm key. To deactivate Audio Off Press the Alarm key again. 4‐6 Alarms Expression MR400 Instructions for Use Alarm Volume The loudness of the alarm sounds can be adjusted (45–86 dB, typical). WARNING Always ensure that the alarm sound setting is appropriate for each patient. The alarm sound volume is adjustable for suitability to various clinical environments. When you use the MR400, always ensure that the alarm sound can be heard above the ambient noise level. Failure to do so may cause a lapse in patient monitoring. To control the alarm volume Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Sound Adjust. The Sound Adjust menu appears. Current settings are displayed. Select Alarm Volume. 1–10 The menu item appears. The current setting is highlighted. Select the desired setting from the menu options. The setting is entered and a momentary sound at the corresponding level is produced Alarm Reset Resetting the alarm results in the following alarm system behaviors: • The auditory alarm signals of physiological alarm conditions cease, enabling the alarm system to respond to a subsequent alarm condition. • Alarm light indications cease. • Alarm flags for any existing alarms continue as long as those alarm conditions exist. • The alarm system is enabled immediately so that it can respond to a subsequent alarm condition. • The visual alarm signals of INOP conditions do not cease as long as the INOP alarm condition exists. The alarm can be reset by pressing the Audio Pause key one time. Expression MR400 Instructions for Use Alarms 4‐7 Managing Alarm Functions WARNINGS • Always respond promptly to any alarm condition; otherwise, treatment of the patient could be delayed. • You should ensure that the current alarm preset is appropriate prior to use on each patient. Failure to do so may cause a lapse in patient monitoring. • Setting the alarm limits to extreme values can render alarm monitoring useless. Also, potential hazard can exist if different alarm monitoring settings are used for the same or similar equipment in any single patient care unit. Ignoring these restrictions may cause a lapse in patient monitoring. The MR400 can be set to provide visual alarm signals only, or both visual and audible alarm signals. The audible alarm states will have no effect on any of the visual alarms displayed by the MR400 (or IP5, if equipped). All settings in the Alarms menu (except Alarm Sound) can be stored and recalled. Restrictions to alarm presets are not provided due to the fast paced work flow, short average duration time of MRI scans, different patient types scheduled for MRI procedures, and direct patient supervision provided during MRI procedures. Note If the MR400 is networked to an IP5, alarm indications occur at both the MR400 and the IP5; and control of alarms, including sound level, is localized to the device (MR400 or IP5) indicating the alarm condition. Showing or Hiding Current Alarm Limits Current high and low alarm limit settings are displayed in the VS box of each monitored parameter by default (except bellows‐derived respiration). To control the display function for the alarm limit settings Step Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. 4‐8 Alarms Expression MR400 Instructions for Use Step Action Select Limits Display. The Limits Display menu appears. The current setting is highlighted. Select the desired option for display of the alarm limit settings: Off On The setting is selected. Adjusting the Alarm Limits WARNING Alarm limits can be set to a wide range of values, including off (with the exception of O2, N2O and FiCO2). It is the responsibility of the operator of the MR400 to ensure that alarm limit values appropriate for each patient are established and set. Failure to do so may cause a lapse in patient monitoring. The MR400 provides versatile methods to control the settings for the patient parameter alarms. Each patient parameter (with the exception of bellows respiration) has a low and high alarm limit setting (see the table on page 4‐22), which can be changed manually or automatically, unless the parameter is off. Alarm Limit Controls Individual alarm limit settings can be adjusted by touching the respective parameter label in the Alarms or the Gas Alarms menu. Expression MR400 Instructions for Use Alarms 4‐9 1 23 4 5 16 15 14 13 12 11 4‐10 Alarms 10 9 8 7 6 Parameter label for alarm limit settings (active adjustment shown) Low button Lower alarm limit setting Upper alarm limit setting High button Off button Clear entry button Enter button Decimal point button 10 Gas Alarms button 11 Alarms button 12 Plus / minus button 13 Keypad 14 Decrement button 15 Current adjustment 16 Increment button Expression MR400 Instructions for Use The Alarm Window Alarm limits have minimum and maximum values that are not adjustable (see page 4‐22). Within the minimum and maximum alarm limits, adjustable lower and upper limit settings establish an alarm window. Vital sign measurements that fall within the alarm window will not result in an physiological alarm. It is only when a vital sign measurement exceeds the alarm window for a monitored parameter that a physiological alarm will be declared. (An illustration is shown below.) 4 5 Parameter name (TEMP in this example) Alarm limit, minimum Lower alarm limit setting Alarm window Alarm limit, maximum Upper alarm limit setting Advanced Alarm Functions The MR400 features advanced alarm functions that can alert you to specific or more extreme physiological conditions. When adjusting these advanced function alarms, the following rules govern the alarm settings: Extreme Bradycardia Alarm Setting The Extreme Bradycardia alarm setting is established by the setting of the Extreme Bradycardia delta value. The Extreme Bradycardia delta value cannot be greater than the difference between the HR low alarm limit setting and the alarm limit minimum. The maximum allowable delta value is 50. See page 5‐24 for setting details. The Extreme Bradycardia delta value will retain its adjusted value as the HR low alarm limit setting is adjusted upward, but will begin to shrink in value as the low alarm limit setting is adjusted closer to the alarm limit minimum. Extreme Tachycardia Alarm Setting The Extreme Tachycardia alarm setting is established the setting of the Extreme Tachycardia delta value. The Extreme Tachycardia delta value cannot be greater than the difference between the HR alarm limit maximum and the high alarm limit setting. The maximum allowable delta value is 50. See page 5‐24 for setting details. Expression MR400 Instructions for Use Alarms 4‐11 The Extreme Tachycardia delta value will retain its adjusted value as the HR high alarm limit setting is adjusted downward, but will begin to shrink in value as the high alarm limit setting is adjusted closer to the alarm limit maximum. Desat Alarm Setting The Desat alarm setting is restricted to a maximum value that is 2 less the SPO2 low alarm limit setting, while the minimum setting can be as low as the alarm minimum. See page 6‐11 for setting details. As long as the SPO2 parameter is on, the Desat alarm value will retain this setting even if the func‐ tion is turned off and on. The SPO2 alarm adjustments are designed to give priority to the Desat alarm setting. Therefore, the SPO2 low and high alarm limits may also be adjusted based on a change made to the Desat alarm setting. Whenever the Desat alarm setting is changed, the following rules determine the lower and upper SPO2 alarm limits: • If the Desat alarm was turned on after being set and turned off, then if the last set value of the SPO2 low alarm limit is less than the Desat alarm setting plus 2, the SPO2 low alarm limit will be set to the Desat alarm setting plus 2. • If the Desat alarm is adjusted upward so that the setting is greater than or equal to the SPO2 low alarm limit minus 2, then the SPO2 low alarm limit will be increased by the system such that the Desat alarm setting plus 2 is always maintained (i.e., the low alarm limit will always move to stay two greater than Desat alarm setting). If low alarm limit is altered due to this scenario, low alarm limit will retain this altered value even if the Desat alarm setting is adjusted downward. • The SPO2 high alarm limit will be adjusted as necessary in relation to the low alarm limit as per the normal behavior of low and high alarm limits. • The SPO2 low alarm limit will be allowed to be adjusted downward only until it is equal to the Desat alarm setting plus 2. No further downward adjustment of low alarm limit will be allowed until the Desat alarm setting is adjusted downward. Setting Alarm Limits Globally Global changes to all of the lower and upper alarm limit settings can be made automatically by pressing the using the 1‐Touch Alarms key. These global changes are calculated using percentages selected in the 1‐Touch High % and the 1‐Touch Low % options; see page 4‐17. During calculations if a patient’s monitored value is so high or low that it would exceed the alarm limit range for the parameter, then the alarm limit will be set to the highest or lowest possible value but not off, as indicated in the table on page 4‐22. For example, if after pressing the 1‐ Touch Alarms key, a patient’s SPO2 upper alarm limit setting was 99 (the highest allowable value), then an alarm will be generated if the patient’s reading reaches 100. (To turn off an alarm limit, see Setting Alarm Limits Individually on page 4‐13.) Also note that setting alarm limits globally may result in a lower SPO2 alarm limit than the default setting. For a patient that has an SpO2 reading of 99%, the new upper limit will be 99 but the new lower limit will be 79 (instead of 85) at a 1‐Touch High % of 20 (factory default). 4‐12 Alarms Expression MR400 Instructions for Use To adjust the upper and lower alarm limit settings for all monitored parameters Step Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. Select 1‐Touch High %. The 1‐Touch High % menu appears. The current setting is highlighted. Select the desired percentage: 5% 10% 15% 20% 30% The setting is selected. Select Lower Window. The Lower Window menu appears. The current setting is highlighted. Select the desired percentage: 5% 10% 15% 20% 30% The setting is selected. Press the 1‐Touch Alarms key. All active alarm limit settings are changed. Setting Alarm Limits Individually Lower and upper alarm limit settings for each parameter can be individually adjusted in the Alarms menu (or in the menu of the parameter that you want to change, by touching the alarm limit settings in parameter’s VS box). In the Alarms menu, lower and upper alarm limit settings for parameters are provided, as shown below. (For information about gas alarms, see chapter 9.) An individual alarm limit setting can be adjusted by touching the lower or upper alarm limit of the respective parameter in the Alarms menu. Expression MR400 Instructions for Use Alarms 4‐13 15 14 13 12 11 10 TEMP – (Temperature) P1 (Sys) – (P1 [Systolic]) P1 (Dia) – (P1 [Diastolic]) P1 (Mean) P2 (Sys) – (P2 [Systolic]) P2 (Dia) – (P2 [Diastolic]) P2 (Mean) CO2 (RESP) – (CO2 [Respiration]) CO2 (Fi) – (CO2 [Fractional inspired]) 10 CO2 (Et) – (CO2 [End-tidal]) 11 NIBP (Mean) 12 NIBP (Dia) – (NIBP [Diastolic]) 13 NIBP (Sys) – (NIBP [Systolic]) 14 SPO2 15 HR – (Heart rate) To adjust the alarm limit settings for a single parameter in the Alarms menu Step Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. 4‐14 Alarms Expression MR400 Instructions for Use Step Action Press the desired parameter label on the Alarms menu: HR SPO2 NIBP (Sys) NIBP (Dia) NIBP (Mean) CO2 (Et) CO2 (Fi) CO2 (RESP) TEMP P1 (Sys) P1 (Dia) P1 (Mean) P2 (Sys) P2 (Dia) P2 (Mean) The background of the selected parameter becomes highlighted (TEMP in this example). Depending upon the alarm limit to be modified, press the Low button or the High button. Parameter label Low button High button In this example, the Low button was selected to adjust the lower alarm limit setting. Expression MR400 Instructions for Use Alarms 4‐15 Step Action Use the increment or the decrement button to adjust the setting. Or, directly input the value using the keypad, the plus / minus button and/or the decimal point button then press the Enter button. (For item locations, see Alarm Limit Controls on page 4‐9.) Adjusted lower limit The current adjustment will reflect the setting. (In this example, the lower limit setting was adjusted from 36 to 33.) Lower alarm limit setting To change the remaining setting, repeat steps 3 and 4. To change any remaining parameters, repeat steps 2, 3, and 4. Press the Main Screen key to close the menu. New limit settings will be indicated in the parameter’s VS box. Restoring Alarm Limit Defaults Whenever the Patient Type setting is changed (see page 3‐11), the MR400 automatically restores the default values to all the alarm limit settings; see page 4‐24 for a listing of the default values. To immediately restore the alarm limits to the default settings Step Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. Select Default Limits. The alarm limit settings are returned to the default values. 4‐16 Alarms Expression MR400 Instructions for Use Enabling Print on Alarm If the MR400 is connected to an IP5 that is equipped with a printer, a printout can be automatically generated when a physiological alarm occurs. See the IP5 IFU for details. Alarms Menu The Alarms menu allows you to configure the MR400 for setup and control of the vital sign alarms. To open the Alarms menu Press the Setup key and then the Alarms key. Setup key Alarms menu Alarms key Gas Alarms button Alarms button Notes • Select the Alarms button to access the alarm limits settings for parameters. • Select the Gas Alarms button to access the alarm limits settings for AGENT and GAS. Expression MR400 Instructions for Use Alarms 4‐17 The following Alarms menu items are available: • 1-Touch High % • 1-Touch Low % • Alarm Sound • Alarm Light • Default Limits • Limits Display To change settings in the Alarms menu Step Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. Select any of the following menu items: 1‐Touch High % 1‐Touch Low % Alarm Sound Alarm Light Default Limits Limits Display For information about these options, see the appropriate sections below. Select the desired menu item. The current setting is highlighted. Select the desired setting from the menu options. The setting is entered. To change other settings, repeat steps 2, 3 and 4. 1-Touch High % Sets a percent value used to calculate the high alarm limits when the 1‐Touch Alarms key is pressed. The current parameter value is bracketed with the percentages set in this menu and in the 1‐Touch Low % menu. The following options are available: • 4‐18 Alarms 5% Expression MR400 Instructions for Use • 10% • 15% • 20% (Default) • 30% To set the upper window See Setting Alarm Limits Globally on page 4‐12. Note If, during calculation, a patient’s monitored value is so high that it exceeds the alarm limit range for the parameter, then the respective alarm limit will be set to the highest value but not off, as indicated in the table on page 4-22. 1-Touch Low % Sets a percent value used to calculate the low alarm limits when the 1‐Touch Alarms key is pressed. The current parameter value is bracketed with the percentages set in this menu and in the 1‐Touch High % menu. The following options are available: • 5% • 10% • 15% • 20% (Default) • 30% To set the lower calculation value See Setting Alarm Limits Globally on page 4‐12. Note If, during calculation, a patient’s monitored value is so low that it exceeds the alarm limit range for the parameter, then the respective alarm limit will be set to lowest possible value but not off, as indicated in the table on page 4-22. Expression MR400 Instructions for Use Alarms 4‐19 Alarm Sound WARNING The alarm sound can be turned off, as indicated by the symbol. Always ensure that the alarm sound setting is appropriate for the monitoring environment and for each patient. The alarm sound volume is adjustable for suitability to various clinical environments. When you use the MR400, always ensure that the alarm sound can be heard above the ambient noise level; otherwise, treatment of the patient could be delayed. Controls the alarm sound (identical to and interactive with Alarms in the Monitor Setup > Sound Adjust menu). The following options are available: • Off turns off the alarm sound, as indicated by the alarm audio off symbol (see page 4‐4). (Only the alarm sound will be disabled; visual alarm indications will continue.) • On turns on the alarm sound, as indicated by the alarm audio armed symbol (see page 4‐ 4). (Default) To control the alarm sound Step Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. Locate Alarm Sound and select the desired setting: Off On The setting is entered. Alarm Light Sets the behavior of the alarm light following the detection of an alarm. The following options are available: 4‐20 Alarms • Continuous illuminates the alarm light for the duration of an alarm condition. (Default) • Temporary illuminates the alarm light for 25 seconds during an alarm condition. (If the MR400 is placed in suspend mode or if the alarm is silenced or paused during this period, then upon exiting the alarm light will restart for 25 seconds.) • Off does not illuminate the alarm light during an alarm condition. Expression MR400 Instructions for Use Note As defined in the table below, the current Alarm Light setting is indicated by the displayed symbol on the information bar (see page 2-14). Alarm Light Setting Displayed Symbol Continuous Temporary Off To adjust the alarm light setting Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Alarm Light. The Alarm Light menu appears. The current setting is highlighted. Select the desired setting from the menu options: Continuous Temporary Off The setting is entered. Default Limits Automatically sets the low alarm limits and high alarm limits for all parameters to the default values (see the table on page 4‐24). To set the alarm limit settings to the default limits See Restoring Alarm Limit Defaults on page 4‐16. Limits Display Controls the visibility of the alarm limit settings in the VS boxes. The following options are available: Expression MR400 Instructions for Use Alarms 4‐21 • Off does not display the alarm limit settings. • On displays the alarm limit settings. (Default) To control the display function for the alarm limit settings Step Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. Select Limits Display. The Limits Display menu appears. The current setting is highlighted. Select the desired option for display of the alarm limit settings: Off On The setting is selected. Adjustable Alarm Limit Ranges With the exception of bellows respiration, each parameter alarm has adjustable limits as indicated in the tables below. Note that the alarm limit numeric values can be set to off, with the exception of O2, N2O, FiCO2. The MR400 also prevents crossover of low and high alarm limit settings, and a minimum number of units separates these low and high settings. When a parameter has been turned off, its alarm limits will be off. Alarm limits are adjustable by the same resolution specified in each parameter's measurement resolution set forth in Appendix A. Note The minimum and maximum values for the low and high limits represent the most extreme settings possible. For some vital signs, these values can be obtained for a low or high alarm limit only if the other limit is off. The table below provides the alarm limit ranges for the MR400. Low Alarm Limit* Minimum Maximum Minimum Maximum Low and High Limit Separation All Off, 30 250 60 250, Off Percent All Off, 50 100 70 100, Off mmHg kPa All Off, 5 Off, 0.7 60 8.0 0.7 90, Off 12.0, Off Vital Sign or Parameter Unit Patient Type HR BPM SPO2 CO2 (Et) 4‐22 Alarms High Alarm Limit* Expression MR400 Instructions for Use Vital Sign or Parameter Low Alarm Limit* Unit Patient Type mmHg kPa All RPM All Off, 4 mmHg kPa All °C °F Maximum 20, Off 2.7, Off 40 20 100, Off Off, -30 Off, -4.0 250 33.3 -30 -4.0 250, Off 33.3, Off All Off, 20.0 Off, 68.0 44.0 111.2 20.0 68.0 44.0, Off 111.2, Off mmHg kPa Adult Off, 30 Off, 4.0 270 36.0 30 4.0 270, Off 36.0, Off — Mean mmHg kPa Adult Off, 20 Off, 2.7 255 34.0 20 2.7 255, Off 34.0, Off — Diastolic mmHg kPa Adult Off, 10 Off, 1.3 245 32.7 10 1.3 245, Off 32.7, Off mmHg kPa Pediatric Off, 30 Off, 4.0 180 24.0 30 4.0 180, Off 24.0, Off — Mean mmHg kPa Pediatric Off, 20 Off, 2.7 160 21.3 20 2.7 160, Off 21.3, Off — Diastolic mmHg kPa Pediatric Off, 10 Off, 1.3 150 20.0 10 1.3 150, Off 20.0, Off mmHg kPa Neo Off, 30 Off, 4.0 130 17.3 30 4.0 130, Off 17.3, Off — Mean mmHg kPa Neo Off, 20 Off, 2.7 120 16.0 20 2.7 120, Off 16.0, Off — Diastolic mmHg kPa Neo Off, 10 Off, 1.3 100 13.3 10 1.3 100, Off 13.3, Off CO2 (Resp) P1 and P2 Temperature NIBP — Systolic NIBP — Systolic NIBP — Systolic Maximum Low and High Limit Separation Minimum CO2 (Fi) Minimum High Alarm Limit* No low alarm *For all alarm limit values that may be displayed in units of kPa, allow +/‐ 0.1 kPa of variance to account for rounding error that may occur when converting from mmHg to kPa. The following table provides the alarm limit ranges for the anesthetic agent gases and oxygen for all patient types. Breath Phase and Gas Unit DES (Et), Expired Desflurane Vol. % Low Alarm Limit High Alarm Limit Minimum Maximum Minimum Maximum Low and High Limit Separation Off, 0.1 18.0 0.1 18.0, Off DES (Fi), Inspired Desflurane Vol. % Off, 0.1 18.0 0.1 18.0, Off ENF (Et) Expired Enflurane Vol. % Off, 0.1 5.0 0.1 5.0, Off ENF (Fi) Inspired Enflurane Vol. % Off, 0.1 5.0 0.1 5.0, Off HAL (Et) Expired Halothane Vol. % Off, 0.1 5.0 0.1 5.0, Off HAL (Fi) Inspired Halothane Vol. % Off, 0.1 5.0 0.1 5.0, Off ISO (Et) Expired Isoflurane Vol. % Off, 0.1 5.0 0.1 5.0, Off ISO (Fi) Inspired Isoflurane Vol. % Off, 0.1 5.0 0.1 5.0, Off Expression MR400 Instructions for Use Alarms 4‐23 Low Alarm Limit High Alarm Limit Minimum Maximum Minimum Maximum Low and High Limit Separation Vol. % Off, 0.1 8.0 0.1 8.0, Off Vol. % Off, 0.1 8.0 0.1 8.0, Off 80 18 100 Breath Phase and Gas Unit SEV (Et) Expired Sevoflurane SEV (Fi) Inspired Sevoflurane N2O (Fi) Inspired Nitrous Oxide Percent O2 (Fi) Inspired Oxygen Percent No low alarm 18 100 Alarm Limit Factory Defaults In the event of power loss, any alarm limit settings that were changed will be lost. All settings that may have been modified to suit a particular patient should be confirmed before monitoring. At power up, the MR400 will automatically set all alarm limits as determined by the default selected in the Edit User Settings menu; see page 3‐15. The factory default alarm limits are listed in the table below. Note You are restricted from making changes to the factory default settings. Adult Vital Sign or Parameter Pediatric Neo Unit Low Limit High Limit Low Limit High Limit Low Limit High Limit Heart Rate BPM 45 160 75 160 90 210 Heart Rate - Extreme Bradycardia BPM 20 20 20 20 20 20 Heart Rate - Extreme Tachycardia BPM 20 20 20 20 20 20 SPO2 Percent 85 Off 90 Off 90 Off SPO2 - Desat Percent 80 80 80 80 80 80 CO2 (Et) mmHg kPa 15 2.0 60 8.0 15 2.0 60 8.0 30 4.0 45 6.0 CO2 (Fi) mmHg kPa No low alarm 0.5 No low alarm 0.5 No low alarm 0.5 RPM 40 40 30 70 P1 / P2 Systolic mmHg kPa 65 8.7 190 25.3 70 9.3 120 16.0 70 9.3 100 13.3 P1 / P2 Mean mmHg kPa 55 7.3 135 18.0 50 6.7 90 12.0 40 5.3 90 12.0 P1 / P2 Diastolic mmHg kPa 40 5.3 125 16.7 40 5.3 70 9.3 35 4.7 50 6.7 CO2 (Resp) 4‐24 Alarms Expression MR400 Instructions for Use Adult Vital Sign or Parameter Pediatric Neo Unit Low Limit High Limit Low Limit High Limit Low Limit High Limit NIBP Systolic mmHg kPa 65 8.7 190 25.3 70 9.3 120 16.0 70 9.3 100 13.3 NIBP Mean mmHg kPa 55 7.3 135 18.0 50 6.7 90 12.0 40 5.3 90 12.0 NIBP Diastolic mmHg kPa 40 5.3 125 16.7 40 5.3 70 9.3 35 4.7 50 6.7 Temperature °C °F 36.0 96.8 39.0 102.2 36.0 96.8 39.0 102.2 36.0 96.8 39.0 102.2 DES (Et), Expired Desflurane Vol. % Off 12.0 Off 12.0 Off 12.0 DES (Fi), Inspired Desflurane Vol. % Off 18.0 Off 18.0 Off 18.0 ENF (Et) Expired Enflurane Vol. % Off 3.4 Off 3.4 Off 3.4 ENF (Fi) Inspired Enflurane Vol. % Off 5.0 Off 5.0 Off 5.0 HAL (Et) Expired Halothane Vol. % Off 1.5 Off 1.5 Off 1.5 HAL (Fi) Inspired Halothane Vol. % Off 2.2 Off 2.2 Off 2.2 ISO (Et) Expired Isoflurane Vol. % Off 2.3 Off 2.3 Off 2.3 ISO (Fi) Inspired Isoflurane Vol. % Off 3.4 Off 3.4 Off 3.4 SEV (Et) Expired Sevoflurane Vol. % Off 4.1 Off 4.1 Off 4.1 SEV (Fi) Inspired Sevoflurane Vol. % Off 6.1 Off 6.1 Off 6.1 N2O (Fi) Inspired Nitrous Oxide Percent No low alarm 80 No low alarm 80 No low alarm 80 O2 (Fi) Inspired Oxygen Percent 18 99 18 99 18 99 *For all alarm limit values that may be displayed in units of kPa, allow +/‐ 0.1 kPa of variance to account for rounding error that may occur when converting from mmHg to kPa. Measurement Limits and Over / Under Values In the table below, the range of values that can be measured for a vital sign item are provided along with the high and low values that, beyond which, an over or under indication will be given. Specifically, a value will be marked as Over (OVR) if the VS value is greater than the given over value, and marked as Under (UND) if the VS value is less than the given under value. Vital Sign or Parameter Numeric Item Units Patient Type Measurement Range Low High Over / Under Values Under Over ECG Heart Rate BPM Adult 30 250 30 250 ECG Heart Rate BPM Ped 30 300 30 300 ECG Heart Rate BPM Neo 30 300 30 300 SPO2 Heart Rate BPM All 30 250 30 250 Expression MR400 Instructions for Use Alarms 4‐25 Vital Sign or Parameter Numeric Item Units Patient Type SPO2 Saturation All P1 and P2 Systolic mmHg P1 and P2 Mean P1 and P2 P1 and P2 Measurement Range Over / Under Values Low High Under Over 100 none none Adult -30 250 -30 250 mmHg Ped -30 250 -30 250 Diastolic mmHg Neo -30 250 -30 250 Pulse Rate BPM All 30 250 30 250 NIBP Systolic mmHg Adult 30 270 30 270 NIBP Systolic mmHg Ped 30 180 30 180 NIBP Systolic mmHg Neo 30 130 30 130 NIBP Mean mmHg Adult 20 255 20 255 NIBP Mean mmHg Ped 20 160 20 160 NIBP Mean mmHg Neo 20 120 20 120 NIBP Diastolic mmHg Adult 10 245 10 245 NIBP Diastolic mmHg Ped 10 150 10 150 NIBP Diastolic mmHg Neo 10 100 10 100 Temperature Temperature °C All 20.0 44.0 20.0 44.0 CO2 (LoFlo option) CO2 (Et) mmHg All 90 none 90 CO2 (LoFlo option) CO2 (Fi) mmHg All 90 none 90 CO2 (LoFlo option) Resp. Rate RPM All 100 none 100 CO2 (AGENT option) CO2 (Et) mmHg All 90 none 90 CO2 (AGENT option) CO2 (Fi) mmHg All 90 none 90 CO2 (AGENT option) Resp. Rate RPM All 100 100 AGENT Desflurane (Et & Fi) All 18.0 none 18.0 AGENT Enflurane (Et & Fi) All 5.0 none 5.0 AGENT Halothane (Et & Fi) All 5.0 none 5.0 AGENT Isoflurane (Et & Fi) All 5.0 none 5.0 AGENT Sevoflurane (Et & Fi) All 8.0 none 8.0 AGENT N2O (Et) All 100 none none AGENT N2O (Fi) All 100 none none AGENT O2 (Fi) All 100 none none Bellows Respiration Resp. Rate RPM All 150 150 Listing of Alarms This section lists patient alarms alphabetically, and technical alarms (INOPs) arranged by the source of the INOP and then alphabetically, irrespective of priority. All alarms and INOPs are listed here; those which can appear on your MR400 will depend on the installed options. 4‐26 Alarms Expression MR400 Instructions for Use Vital Sign Value State A vital sign value is considered missing (as indicated by three dashes, ‐ ‐ ‐) when the vital sign has produced a value since the monitor was turned on, but can no longer produce a value. Examples of the values that could become missing during normal use, include: • ECG heart rate value if the leads are removed. • SPO2 value during No Probe, Probe Off, et cetera. • Temperature value if the probe was removed. • Invasive pressure values if the transducer is removed. When a value becomes missing due to an INOP, an INOP alarm will be present. And, a patient alarm—due to the missing value—will be present as well. Therefore, the system can have an INOP alarm, and a patient alarm, active at the same time and from the same cause. WARNING If, during use, an alarm condition listed below results in a loss of patient monitoring capability, employ an alternate means as needed to prevent a lapse in patient monitoring; otherwise, treatment of the patient could be delayed. Patient and INOP Alarms The measurement labels and abbreviations for pressure, temperature, SpO2, CO2 and anesthetic agent alarms are explained in the individual chapters. The following table contains a listing of patient alarms arranged by vital sign or parameter. The parameter must be on for the respective alarm detections to be enabled; see page 3‐18. Note In the case of missing data (- - -), an alarm will occur only if a valid numeric was previously displayed but can no longer be produced; see page 2-20 for details. Patient Alarm From Extreme Brady ECG, SPO2, P1 The heart rate measurement has (or P2) violated the Extreme Bradycardia alarm setting. Red flag in ECG alarm flag area, flashing red heart rate numeric in the ECG VS box and in the SPO2 VS box, red alarm light, high priority alarm tone Extreme Tachy ECG, SPO2, P1 The heart rate measurement has (or P2) violated the Extreme Tachycardia alarm setting. Red flag in ECG alarm flag area, flashing red heart rate numeric in the ECG VS box and in the SPO2 VS box, red alarm light, high priority alarm tone Violated heart rate value ECG, SPO2, P1 The heart rate measurement has (or P2) violated an alarm limit setting. Flashing yellow heart rate numeric in the ECG VS box and in the SPO2 VS box, yellow alarm light, medium priority alarm tone Expression MR400 Instructions for Use Condition Indication Alarms 4‐27 Patient Alarm From Condition Indication Missing heart rate data ECG, SPO2, P1 The heart rate data, once present, Flashing yellow dashes (- - -) in the heart rate (or P2) can no longer be produced. numeric in the ECG VS box and in the SPO2 VS box, yellow alarm light, medium priority alarm tone Over maximum heart rate value ECG, SPO2, P1 The heart rate measurement has (or P2) violated the upper parameter range. Flashing red heart rate numeric alternating between OVR and the heart rate value in the ECG VS box and in the SPO2 VS box, red alarm light, high priority alarm tone Under minimum heart rate value ECG, SPO2, P1 The heart rate measurement has (or P2) violated the lower parameter range. Flashing red heart rate numeric alternating between UND and the heart rate value in the ECG VS box and in the SPO2 VS box, red alarm light, high priority alarm tone Desat SPO2 SPO2 has detected a desaturation event. Red flag in ECG alarm flag area, flashing red SpO2 numeric, red alarm light, high priority alarm tone Violated arterial oxygen saturation value SPO2 The arterial oxygen saturation measurement has violated an alarm limit setting. Flashing yellow SpO2 numeric in the SPO2 VS box, yellow alarm light, medium priority alarm tone Missing arterial oxygen saturation data SPO2 The arterial oxygen saturation data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the SpO2 numeric in the SPO2 VS box, yellow alarm light, medium priority alarm tone Apnea CO2, AGENT The apnea time delay setting has been exceeded. Red flag in the CO2 or RESP alarm flag area, Flashing red respiration rate numeric, red alarm light, high priority alarm tone Note Apnea alarm flag appears in either the CO2 or the RESP alarm flag area, based on the RESP source. Violated EtCO2 value CO2, AGENT The end-tidal CO2 measurement has violated an alarm limit setting. Flashing yellow EtCO2 numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Missing EtCO2 data CO2, AGENT The end-tidal CO2 data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the EtCO2 numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone Violated FiCO2 value CO2, AGENT The fractional inspired CO2 measurement has violated an alarm limit setting. Flashing yellow FiCO2 numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Missing FiCO2 data CO2, AGENT The fractional inspired CO2 data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the FiCO2 numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone 4‐28 Alarms Expression MR400 Instructions for Use Patient Alarm From Condition Indication Violated CO2 respiration rate value CO2, AGENT The CO2 respiration rate measurement has violated an alarm limit setting. Depending upon RESP VS box configuration: Missing CO2 respiration rate data CO2, AGENT The CO2 respiration rate data, once present, can no longer be produced. • Flashing yellow respiration rate numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone, or • Flashing yellow respiration rate numeric in the RESP VS box, yellow alarm light, medium priority alarm tone • And where OVR displayed if the value is greater than the highest specified • And where UND if the value is less than the lowest specified (AGENT option only) Depending upon RESP VS box configuration: • Flashing yellow dashes (- - -) in the respiration rate numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone, or • Flashing yellow dashes (- - -) in the respiration rate numeric in the RESP VS box, yellow alarm light, medium priority alarm tone Violated invasive blood pressure systolic value P1 (and P2) The P1 (or P2) invasive blood Flashing yellow systolic numeric in the P1 VS pressure systolic measurement has box, yellow alarm light, medium priority alarm violated an alarm limit setting. tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Violated invasive blood pressure mean value P1 (and P2) The P1 (or P2) invasive blood pressure mean measurement has violated an alarm limit setting. Flashing yellow mean numeric in the P1 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Violated invasive blood pressure diastolic value P1 (and P2) The P1 (or P2) invasive blood pressure diastolic measurement has violated an alarm limit setting. Flashing yellow diastolic numeric in the P1 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Missing invasive blood pressure data P1 (and P2) The P1 (or P2) invasive blood pressure data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the systolic, diastolic and mean numerics in the P1 VS box, yellow alarm light, medium priority alarm tone Violated primary agent Et value AGENT The end-tidal measurement for the Flashing yellow primary agent Et numeric in the primary agent gas has violated an AGENT VS box, yellow alarm light, medium alarm limit setting. priority alarm tone, where OVR displayed if the value is greater than the highest specified Violated primary agent Fi value AGENT The fractional inspired measurement for the primary agent gas has violated an alarm limit setting. Expression MR400 Instructions for Use Flashing yellow primary agent Fi numeric in the AGENT VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Alarms 4‐29 Patient Alarm From Condition Violated secondary agent Et value AGENT The end-tidal measurement for the Flashing yellow secondary agent Et numeric in secondary agent gas has violated the AGENT VS box, yellow alarm light, an alarm limit setting. medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Violated secondary agent Fi value AGENT The fractional inspired measurement for the secondary agent gas has violated an alarm limit setting. Flashing yellow secondary agent Fi numeric in the AGENT VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Missing primary and secondary agent data AGENT The primary and secondary agent data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the primary and secondary numerics in the AGENT VS box, yellow alarm light, medium priority alarm tone Violated N2O value AGENT The N2O measurement has violated an alarm limit setting. Flashing yellow N2O numeric in the GAS VS box, yellow alarm light, medium priority alarm tone Missing N2O data AGENT The N2O data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the N2O numeric in the GAS VS box, yellow alarm light, medium priority alarm tone Violated O2 value AGENT The O2 measurement has violated Flashing yellow O2 numeric in the GAS VS an alarm limit setting. box, yellow alarm light, medium priority alarm tone Violated O2 value AGENT The O2 measurement is less than 18 percent. Missing O2 data AGENT The O2 data, once present, can no Flashing yellow dashes (- - -) in the O2 numeric longer be produced. in the GAS VS box, yellow alarm light, medium priority alarm tone Missing bellows respiration rate data RESP The bellows respiration data, once Flashing yellow dashes (- - -) in the respiration present, can no longer be rate numeric in the RESP VS box, yellow alarm produced. light, medium priority alarm tone Violated temperature value TEMP The temperature measurement has violated an alarm limit setting. Flashing yellow temperature numeric in the TEMP VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Missing temperature data TEMP The temperature data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the temperature numeric in the TEMP VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Violated non-invasive blood pressure systolic value NIBP The non-invasive blood pressure systolic measurement has violated an alarm limit setting. Flashing yellow systolic numeric in the NIBP VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified 4‐30 Alarms Indication Flashing red O2 numeric in the GAS VS box, red alarm light, high priority alarm tone Expression MR400 Instructions for Use Patient Alarm From Condition Indication Violated non-invasive blood pressure mean value NIBP The non-invasive blood pressure Flashing yellow mean numeric in the NIBP VS mean measurement has violated an box, yellow alarm light, medium priority alarm alarm limit setting. tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Violated non-invasive blood pressure diastolic value NIBP The non-invasive blood pressure Flashing yellow diastolic numeric in the NIBP diastolic measurement has violated VS box, yellow alarm light, medium priority an alarm limit setting. alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Missing non-invasive blood pressure data NIBP The non-invasive blood pressure data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the systolic, diastolic and mean numerics in the NIBP VS box, yellow alarm light, medium priority alarm tone Technical (INOP) Alarms and Other Status Flags The following table contains a listing of the INOP and other status alarm flag messages, locations, tone indications, and where applicable possible solutions. ECG Message, Location, Indication Lead Fail ECG alarm flag area, blue alarm light, INOP alarm tone What to Do An ECG lead (or electrode) required to measure the lead view is faulty or disconnected: • Ensure that the ECG lead cable is connected to the wECG module, and that the wECG module has sufficient battery power. • Ensure that each ECG lead cable clip is connected to the Quadtrode electrode contact. (Examine the ECG VS box for indications of a contact problem, where LL = left leg, LA = left arm, and RA = right arm, and LL, LA, RA, = RL [right leg] or all leads.) • Replace the ECG lead cable. • Replace the Quadtrode electrode. Notes • The error message can be displayed for trace A and/or for trace B. • May also be displayed when high DC offsets are present on an input lead. Expression MR400 Instructions for Use Alarms 4‐31 Message, Location, Indication What to Do Lead Saturation Baseline offset of the ECG input signal is too large for process and display of the waveform. Replace the Quadtrode electrode. ECG alarm flag area, blue alarm light, INOP alarm tone Note The error message can be displayed for trace A and/or for trace B. SPO2 Message, Location, Indication What to Do Bad Probe The SpO2 probe is defective. Replace the SpO2 probe. SPO2 alarm flag area, blue alarm light, INOP alarm tone Erratic SPO2 alarm flag area, blue alarm light, INOP alarm tone The SpO2 attachment may be improperly applied or positioned on the patient; or, the probe is faulty. • Check the alignment of the clip (or grip) on the patient. • Replace the SpO2 probe. If the message persists, contact technical support or authorized service personnel. HW Fail A hardware or other failure has occurred in the wSpO2 module. Replace the wSpO2 module. SPO2 alarm flag area, blue alarm light, INOP alarm tone If the failure persists, immediately remove the MR400 and the wSpO2 module from service then contact technical support or authorized service personnel, as the system must not be used on any patient requiring SpO2 measurement. Intrfernce Interference due to attachment misalignment or incorrect attachment positioning: SPO2 alarm flag area, blue alarm light, INOP alarm tone • Check the alignment of the clip (or grip) on the patient site. • Try a different limb or site. • Ensure that the module is placed outside of the MR bore. • Reposition the wSpO2 module (see page 6-6. • Replace the clip (or grip). Low Perf SPO2 alarm flag area, blue alarm light, INOP alarm tone Accuracy may be compromised due to low perfusion. The tissue at the SpO2 attachment site may be too opaque, thick or cold. • If the clip (or grip) is positioned on a finger, check for long, artificial or polished nails. Remove any nail polish or relocate the attachment if needed. • Try another attachment site, like a toe. • Try rubbing or warming the limb to stimulate circulation. No Probe SPO2 alarm flag area, blue alarm light, INOP alarm tone 4‐32 Alarms The SpO2 probe is not attached or is improperly attached to the wSpO2 module. Check the connection of the probe to the module. Reconnect the probe or, if the connection was good, replace the probe. Expression MR400 Instructions for Use Message, Location, Indication What to Do Noise Excessive patient motion, the MRI scan sequence or electrical interference is causing noise in the SpO2 system: SPO2 alarm flag area, blue alarm light, INOP alarm tone • Stop any patient motion, especially at the monitored site. • Ensure that the module is placed outside of the MR bore. • Ensure the clip (or grip) is positioned in a way that does not expose it to bright ambient light. Non-Pulsat SPO2 alarm flag area, blue alarm light, INOP alarm tone The detected pulse is too weak for reliable reporting of SpO2 measurements: • Check the patient’s condition. • Check the clip (or grip) position and alignment on the patient then re-position or re-apply as necessary. • Try a different limb or site. Probe Off SPO2 alarm flag area, blue alarm light, INOP alarm tone Pulse? SPO2 alarm flag area, blue alarm light, INOP alarm tone Searching SPO2 alarm flag area, blue alarm light, INOP alarm tone The SpO2 attachment is not properly applied to the patient. Reposition the clip (or grip) on the patient. Pulse reading is questionable. The SpO2 attachment may not be applied optimally or the tissue at the application site may be too opaque: • Check the alignment of the clip (or grip) on the patient. • Try a different limb or site. The SpO2 attachment was just applied or it has shifted position on the patient: • If the clip (or grip) was just applied, allow about 20 seconds for the system to lock on to a good pulse. • Check the clip (or grip) position and reposition it if necessary. • Replace the SpO2 probe. If the message persists, contact technical support or authorized service personnel. Wrong Prb SPO2 alarm flag area, blue alarm light, INOP alarm tone The probe attached to the wSpO2 module is not the correct type. Attach the correct probe to the module. CO2 / CO (RESP) / AGENT Message, Location, Indication What to Do Check CO2 Sampling Line Reduced flow has been detected by the CO2 system. Check the sampling line for pinches or obstructions then clear any pinch or replace if necessary. CO2 alarm flag area, blue alarm light, INOP alarm tone CO2 Cal Fail CO2 failed to calibrate. Retry calibration. CO2 alarm flag area, blue alarm light, INOP alarm tone If the message persists, contact technical support or authorized service personnel. Expression MR400 Instructions for Use Alarms 4‐33 Message, Location, Indication What to Do CO2 Low Flow Message may appear when the sampling line is initially connected; allow the a few seconds for the flow to be established. Otherwise, the detected flow rate is 10 percent less than nominal; in this case, check the sampling line for pinches or obstructions then clear any pinch or replace if necessary. CO2 alarm flag area, blue alarm light, INOP alarm tone If the message persists, contact technical support or authorized service personnel. Check for CO2 Occlusion Detected flow through the sampling line is less than 40 ml/min or the water trap may be full of fluid: CO2 alarm flag area, blue alarm light, INOP alarm tone • Check the sampling line for obstructions and replace it if necessary. • Check the fluid level in the water trap and replace it if necessary. If the message persists, contact technical support or authorized service personnel. CO2 Out Of Range CO2 alarm flag area, blue alarm light, INOP alarm tone The calculation value is greater than the upper CO2 limit. Perform readings to confirm patient’s physiological condition. If the message persists, contact technical support or authorized service personnel. CO2 Sensor Faulty CO2 bench detected a hardware or sensor error. Cycle AC mains power. CO2 alarm flag area, blue alarm light, INOP alarm tone If the message persists, contact technical support or authorized service personnel. CO2 Sensor Over Temp The CO2 sensor is above the specified operating temperature. Confirm that the MR400 is operating within the required environmental conditions (see Appendix A); if outside the specified range, move the MR400 to an area that is within limits. CO2 alarm flag area, blue alarm light, INOP alarm tone If the problem persists, stop all monitoring activities and contact technical support or authorized service personnel. CO2 Warming Up CO2 is warming to operating temperature. Allow the process to complete, about 2 minutes. CO2 alarm flag area, blue alarm light, INOP alarm tone CO2 Zero Required Zero calibration of the CO2 module is needed; see page 7-15 for details. CO2 alarm flag area, blue alarm light, INOP alarm tone Magnetic Field Too High CO2 alarm flag area, blue alarm light, INOP alarm tone The gauss limit has been exceeded, and the AGENT option can no longer function. Position the MR400 per the product labeling; see page 3-2. HW Fail CO2 module was not found during initialization. Cycle AC mains power. CO2 alarm flag area, blue alarm light, INOP alarm tone If the message persists, contact technical support or authorized service personnel. Low O2 The inspired O2 value has dropped below 18.0 AGENT alarm flag area, blue alarm light, INOP alarm tone Motor Speed Error The MR400 is too close to the MR magnet. CO2 alarm flag area, blue alarm light, INOP alarm tone Ensure that the MR400 has been positioned correctly; see page 3-2. If the message persists, contact technical support or authorized service personnel. 4‐34 Alarms Expression MR400 Instructions for Use Message, Location, Indication What to Do Multiple Agents More than one anesthetic agent gas was detected in a given breath phase, with a total MAC of the detected mix is less than 3 MAC. AGENT alarm flag area, blue alarm light, INOP alarm tone Note If multiple agents have been detected with a total MAC of the detected mix greater than 3 MAC then this message will be accompanied by a yellow alarm light and medium priority alarm tone. O2 Sensor Not Present AGENT alarm flag area, blue alarm light, INOP alarm tone Possible hardware failure associated with the O2 sensor. Ensure that the O2 sensor is secure in the receptacle; see page 14-13. If the message persists, contact technical support or authorized service personnel. Occlusion Occluded sample line detected at start up: CO2 alarm flag area, blue alarm light, INOP alarm tone • Check the sampling line for obstructions and replace it if necessary. • Check the fluid level in the water trap and replace it if necessary. If the message persists, contact technical support or authorized service personnel. O2 Sensor Fail O2 sensor has failed or expired. Replace the O2 sensor; see page 14-13. CO2 alarm flag area, blue alarm light, INOP alarm tone If the message persists, contact technical support or authorized service personnel. Occlusion at Start Occluded sample line detected at start up: CO2 alarm flag area, blue alarm light, INOP alarm tone • Check the sampling line for obstructions and replace it if necessary. • Check the fluid level in the water trap and replace it if necessary. If the message persists, contact technical support or authorized service personnel. Performing CO2 Zero Displayed while zeroing CO2. Allow the process to complete. CO2 alarm flag area, blue alarm light, INOP alarm tone Persistent CO2 Occlusion Reduced CO2 flow has been detected for over 2 minutes. Check for pinches or obstructions in the sampling line. Clear any pinch, or replace the accessory if necessary. CO2 alarm flag area, blue alarm light, INOP alarm tone If the message persists, contact technical support or authorized service personnel. P1 (or P2) Message, Location, Indication What to Do Catheter Disconnected The catheter cannot be detected. Check all catheter connections to and from the transducer. P1 (or P2) alarm flag area, yellow alarm light, medium priority alarm tone Hardware Error P1 (or P2) alarm flag area, blue alarm light, INOP alarm tone A hardware error has been detected in the IBP system. Contact technical support or authorized service personnel. Expression MR400 Instructions for Use Alarms 4‐35 Message, Location, Indication What to Do Transducer Faulty A electrical transducer malfunction has been detected. P1 (or P2) alarm flag area, yellow alarm light, medium priority alarm tone Transducer Not Present P1 (or P2) alarm flag area, yellow alarm light, medium priority alarm tone • Check the transducer cable connection. • Replace the transducer. • Contact technical support or authorized service personnel if the message persists. An IBP transducer was not found. Ensure that the transducer cables are connected to the transducer and MR400. If the message persists, contact technical support or authorized service personnel. TEMP Message, Location, Indication What to Do Cal Error TEMP alarm flag area, blue alarm light, INOP alarm tone Calibration error. Reconnect the sensor and then retry. Contact technical support or authorized service personnel if the message persists. Chk Probe TEMP alarm flag area, blue alarm light, INOP alarm tone The temperature sensor connection is bad, has a sharp bend, or is damaged: • Ensure that the sensor is inserted completely in the temperature port on the patient connection panel. • Remove any sharp bends in the temperature sensor. • If the message persists after performing the above actions, then the temperature sensor most likely is damaged and readings cannot be provided. Try a new sensor. Exp Probe TEMP alarm flag area, blue alarm light, INOP alarm tone The temperature probe connected to the MR400 is not the proper type. Insert the correct type of temperature probe into the temperature port. HW Fail TEMP alarm flag area, blue alarm light, INOP alarm tone Temperature hardware failure detected. Contact technical support or authorized service personnel. No Probe The temperature probe is not properly connected to the MR400. Insert a temperature probe into the temperature port on the patient connection panel. TEMP alarm flag area, blue alarm light, INOP alarm tone Wrong Prb TEMP alarm flag area, blue alarm light, INOP alarm tone 4‐36 Alarms The temperature probe connected to the MR400 is not the proper type. Insert the correct type of temperature probe into the temperature port. Expression MR400 Instructions for Use NIBP Message, Location, Indication What to Do Communication Error An internal NIBP error has occurred. Discontinue use of NIBP and contact technical support or authorized service personnel. NIBP alarm flag area, blue alarm light, INOP alarm tone Deflation Timeout NIBP alarm flag area, red alarm light, high priority alarm tone Cuff deflation has timed out; displayed if the NIBP cuff deflation period is greater than 80 seconds (neonatal patient type) or is greater than 150 seconds (adult and pediatric patient types): • Check the patient. • Check for proper cuff size and placement. • Check the cuff and hoses for pinching. If the message persists, contact technical support or authorized service personnel. Hardware Error NIBP alarm flag area, blue alarm light, INOP alarm tone Inflation Timeout NIBP alarm flag area, blue alarm light, INOP alarm tone NIBP hardware failure detected. Discontinue use of NIBP and contact technical support or authorized service personnel. Cuff inflation has timed out: • Check the patient. • Check the cuff and hoses for pinching or leaks. If the message persists, contact technical support or authorized service personnel. Measurement Failed NIBP alarm flag area, blue alarm light, INOP alarm tone The NIBP measurement has failed: • Check the patient. • Check for proper cuff size and placement. • Check the cuff and hoses for pinching or leaks. If the message persists, contact technical support or authorized service personnel. Measurement Timeout NIBP alarm flag area, blue alarm light, INOP alarm tone The NIBP measurement has timed out: • Check the patient. • Check for proper cuff size and placement. • Check the cuff and hoses for pinching or leaks. Check the cuff condition and placement on the patient. Module Not Calibrated NIBP is not calibrated. Contact technical support or authorized service personnel. NIBP alarm flag area, blue alarm light, INOP alarm tone Over Pressure NIBP alarm flag area, blue alarm light, INOP alarm tone The allowed pressure for the type of patient has been exceeded: • Ensure that the patient is immobilized and not applying pressure to the cuff. • Check the cuff condition and placement on the patient. • Make sure that the hose is not pinched. If the message persists, contact technical support or authorized service personnel. Pressure Correction NIBP alarm flag area, blue alarm light, INOP alarm tone Residual Pressure NIBP alarm flag area, blue alarm light, INOP alarm tone A pressure correction error has been detected: • Ensure that the patient is immobilized and not applying pressure to the cuff. • Check the cuff condition and placement on the patient. Residual pressure remains in the NIBP system. Disconnect the NIBP hose from the patient connection panel and then restart the procedure. Expression MR400 Instructions for Use Alarms 4‐37 Other Status Indications Message, Location, Indication Condition All Alarms Are Off All alarm limits have been turned off. System message area, no alarm light, no alarm tone Audio Off Alarm sound is silenced. System message area, no alarm light, no alarm tone Audio Paused Alarm sound is paused. System message area, no alarm light, no alarm tone Change NIBP Cuff The Patient Type was changed so the NIBP cuff should be changed. System message area, no alarm light, no alarm tone Check Alarm Vol Power was just turned on, settings were recalled. System message area, no alarm light, no alarm tone The charge level is low for the wECG module battery (or batteries). Install at least one charged battery into the wECG module. status information pane, blue alarm light, INOP alarm tone WARNING A red battery symbol indicates that the module batteries have fallen below the required operational output and module shutdown with loss of monitoring will occur. Immediately replace the module batteries to avoid a loss in monitoring. No communication between the MR400 and wECG module. Ensure that the wECG module is set to the same network channel as the MR400 cart. If both are the same, use an alternate setting. If the indication persists, contact technical support or authorized service personnel. Status information pane, no alarm light, no alarm tone ECG Test Signal The ECG Test Signal is on. System message area, no alarm light, no alarm tone No communication between the MR400 and IP5. Ensure that the IP5 is set to the same network channel as the MR400 cart. If both are the same, use an alternate setting. If the indication persists, contact technical support or authorized service personnel. Status information pane, no alarm light, no alarm tone 4‐38 Alarms Expression MR400 Instructions for Use Message, Location, Indication Condition Charge level of the cart batteries is low. Connect the MR400 cart to external power and allow the batteries to charge. WARNING A red battery symbol indicates that the main batteries in the MR400 have fallen below the required operational output and system shutdown with loss of monitoring will occur. Immediately locate an AC outlet and connect the MR400 to avoid a loss in monitoring. Status information pane, blue alarm light, INOP alarm tone Overscale ECG alarm flag area, no alarm light, no alarm tone Real Tones Disabled The size of the ECG waveform is too large and the tops of the ECG waveforms are clipped (that is, cut off). Reduce the size using the Scale setting; see page 5-28. Normal audio sounds are suspended as a volume adjustment is in progress. System message area, no alarm light, no alarm tone Simulation The system is in simulation mode. Turn off power to exit this mode. System message area, no alarm light, no alarm tone Charge level of the wSpO2 module battery is low. Install a charged battery into the wSpO2 module. WARNING A red battery symbol indicates that the module batteries have fallen below the required operational output and module shutdown with loss of Status information pane, blue monitoring will occur. Immediately replace the module batteries to avoid a alarm light, INOP alarm tone loss in monitoring. No communication between the MR400 and wSpO2 module. Ensure that the wSpO2 module is set to the same network channel as the MR400 cart. If both are the same, use an alternate setting. If the indication persists, contact technical support or authorized service personnel. Status information pane, no alarm light, no alarm tone Expression MR400 Instructions for Use Alarms 4‐39 4‐40 Alarms Expression MR400 Instructions for Use CHAPTER 5 Monitoring ECG Electrocardiogram (ECG) monitoring inside the MRI environment is unique and requires additional precautions to permit safe patient procedures. It is always important to remember that the risk of radio frequency (RF) heating is ever present when any electrical conductors (for example, ECG lead cables) are placed in the MR system bore. By following the operating precautions, warnings and the guidelines below, these risks can be minimized. The ECG parameter is intended for ECG monitoring mode and not diagnostic ECG monitoring. WARNINGS • The MR400 is not intended for use with patients using pacemakers or electrical stimulators. • Arrhythmias, erratic heartbeats, operation of electrical stimulators, pacemakers and patient motion can result in inaccurate readings. Rate meters may continue to count pacemaker rates during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. If questionable readings are obtained, check the patient's vital signs by alternate means before administering medication. CAUTION Pacer pulses are not specifically rejected by the MR400 and may be treated as part of MRI gradient noise. Gradient filtering attempts to remove high frequency pulse-shaped waveforms from the ECG signal which may resemble pacer waveforms, and it is possible that the pacer waveform may be removed with the gradient noise. ECG Monitoring Considerations for the MR Environment Monitoring ECG in the MR environment is particularly challenging because of the inherent distortion of the ECG waveform caused by the combined electromagnetic fields generated by the MRI scanner. In particular, certain ECG interference appears when the patient is placed inside the bore before scanning begins. These blood flow induced distortions of the ECG are due to the large amount of blood moving through the vessels of the heart (aorta). Blood (a very good electrical conductor) moving through the large magnetic field of the MR produces an electrical potential that adds to the ECG signal. This induced electrical potential is seen primarily as an augmentation of the ECG T‐wave amplitude, although other non‐specific waveform changes are also apparent on the ECG. Since an elevated T‐wave or ST segment will be associated with true physiologic disorders, the static magnetic field‐induced ECG‐distortions may prohibit effective ECG monitoring in the MRI. For this reason, a baseline recording of the ECG prior to sliding the patient inside the bore or outside the MR magnet room will be necessary. Expression MR400 Instructions for Use Monitoring ECG 5‐1 The proper placement of the ECG electrodes in the MRI is critical to reducing the blood flow induced distortion of the ECG waveform. With proper strategic placement of the ECG electrodes and minimization of ECG lead cable length, this blood flow induced distortion can be kept to a minimum, as discussed in this section. Additional artifacts caused by the static, gradient and RF electromagnetic fields can severely distort the ECG, making observation of the morphologic changes and detection of arrhythmia quite difficult. Monitoring using a different ECG lead view (I, II, III, AVL, AVR, AVF) will minimize some of these artifacts. wECG Module and ECG Lead Cable The wECG module and lead cable are intended for patient uses when continuous ECG monitoring or cardiac gating are required. The wECG module and lead cable may be used in the MR system bore, although the module must not be placed within 28 cm (11 inches) of the MRI field of view (FOV). For wECG module details, see page 2‐9. The components of the ECG lead cable are detailed below. Connector ECG lead cable label identifier Velcro storage strap Cable trunk with foam insulator Lead wires Lead cable clips CAUTIONS • If dropped, the wECG module must be verified for correct operation before use; see page 14-12. • Guard against the accidental ingress of liquid into the module, as measurements made by the device can be adversely affected. Note Refer to your facility's biohazard procedure for disposal of ECG lead cables when they become unusable. Usually cables are disposed of as medical waste per facility procedures. 5‐2 Monitoring ECG Expression MR400 Instructions for Use Quadtrode Electrodes The Quadtrode electrodes serve as patient connection points for the ECG lead cable clips. Different Quadtrode electrodes are available to meet each monitoring requirement. The components of a Quadtrode electrode are detailed below. Foam insulator Electrode contact (four contacts are provided on the standard and neonatal types, and one contact on the CV type Lead retainer (not present on CV and neonatal types) Work Flow for ECG Monitoring When monitoring ECG, many factors will impact the performance and operation of the parameter, including: • The site selected on the patient, • The ECG lead cable and Quadtrode electrode pairing, • The selected filter and lead view setting for the monitor, • Module placement and ECG lead cable routing; and, • Scan sequence selection and scan sequence parameters on the MRI console. To prepare a patient for ECG monitoring Step Action Select the Patient Type. See Selecting the Patient Type on page 3‐11. According to the patient type, their body mass, and the study to be performed, choose a recommended ECG lead cable and Quadtrode electrode pair. See Selecting the ECG Lead Cable and Quadtrode Electrode Type on page 5‐5. Decide where to apply the Quadtrode electrode to the patient. See Identifying the Placement Site for the Quadtrode Electrode on page 5‐7. Expression MR400 Instructions for Use Monitoring ECG 5‐3 Step Action Prep the placement site(s) on the patient and then apply the Quadtrode electrode to the patient. See Preparing the Quadtrode Electrode Site on page 5‐11. Attach the lead cable clips to the contacts on the Quadtrode electrode. See Attaching the ECG Lead Cable on page 5‐12. Evaluate the ECG signal strength and make adjustments as needed before the patient enters the scanner. See Checking the ECG Signal Strength on page 5‐16. Position the patient, the lead cable and the wECG module for scanning. See Positioning the ECG Lead Cable and wECG Module for Scanning on page 5‐19. Select the lead view and Filter Mode for the study. See Changing the Lead View on page 5‐17 and Filter Mode on page 5‐31. Before sliding patient inside the bore, or outside the MR magnet room, establish a baseline recording of the patient’s ECG signal. 10 Slide the patient into the bore, but do not start scanning. Then, recheck the ECG waveform for usability by evaluating it for distortion. If ECG waveform has become excessively distorted and the heart rate numeric is not functioning properly in the bore, then the ECG lead cable may require rerouting and / or a new electrode placement site must be selected before starting the scan sequence. (Also see Minimizing ECG Waveform Noise on page 5‐18.) 5‐4 Monitoring ECG Expression MR400 Instructions for Use Step 11 Action Begin scan sequence and observe the ECG waveform. If the ECG waveform becomes compromised during scanning, then change the lead view and/or the Filter Mode on the MR400. Note ECG performance during MRI scanning can be further improved by modifying scan sequence parameters at the MRI console. Changing any of these parameters directly alters image quality so precaution must be taken to not overwhelmingly affect the desired image characteristics: 12 • Increase TE (Echo Time) • Increase TR (Repetition Time) • Increase TI (Inversion Time) • Increase / change the imaging plane (for example, sagittal to axial) • Turn off fat suppression • Decrease the PNS level • Decrease the gradient strength After scanning, disconnect the wECG module from the patient. Then store the wECG module in the module holder. Loop the cable trunk with foam insulator then secure it using the Velcro storage strap to keep the excess cable length from touching the floor; see page 2‐12. Selecting the ECG Lead Cable and Quadtrode Electrode Type ECG lead cables and Quadtrode electrodes are proton emissions compliant, will not distort the MR image, and are designed to provide the maximum patient safety and MRI performance: • Only use the specified ECG lead cables with the MR400, as these are specially constructed to avoid patient heating by reducing the amount of radio frequency (RF) energy that can flow through the wires and with a shorter length to reduce the potential for cable looping. The type of lead cable needed will depend upon the type of Quadtrode electrode being used. • Only use the specified Quadtrode electrode with the MR400, as this will minimize the possible risk of electrode heating during MRI procedures and reduce the amount of MRI‐ generated artifacts on the ECG waveform. The type of Quadtrode electrode needed will depend generally upon the patient type, gender and weight. (Regardless of the type, the Quadtrode electrode will be considered a single item when discussed in this text.) Expression MR400 Instructions for Use Monitoring ECG 5‐5 The table below highlights the recommended uses of ECG lead cables and Quadtrode electrodes. ECG Lead Cables and Quadtrode Electrodes - Recommended Pairings CV ECG lead cable CV Quadtrode Electrode Purpose: • For patients weighing more than 10 kg (22 pounds) • Best for female and overweight patients (that is, in situations where placement would be difficult using the standard Quadtrode electrode) Version and Part Number: Part Number: REF 989803179041 AAMI: REF 989803193721 IEC: REF 989803193751 Standard ECG lead cable Quadtrode Electrode (standard) Purpose: • For patients weighing more than 10 kg (22 pounds) • Quick application Version and Part Number: Part Number: REF 989803179031 AAMI: REF 989803193731 IEC: REF 989803193761 Neonatal ECG lead cable Purpose: • For infants weighing less than 10 kg (22 pounds) • Quick application Neonatal (Neo) Quadtrode Electrode Part Number: REF 989803179051 Version and Part Number: AAMI: REF 989803193741 IEC: REF 989803193771 5‐6 Monitoring ECG Expression MR400 Instructions for Use Identifying the Placement Site for the Quadtrode Electrode WARNING Warning Ensure that the location of the electrodes is compliant to the requirements of your electrosurgical equipment to reduce the possibility of burns; however, note that monitoring in the MR environment requires specific electrode placement. (See page 5-3 to ensure the highest quality ECG signal. For questions and guidance regarding placement, contact technical support; see page 14-16 for contact information.) According to the patient type or weight, placement of the Quadtrode electrode over the heart is important for optimal ECG performance. Note For placement purposes, we define to the breast line as an imaginary horizontal line that extends across the nipple areas of a patient of normal weight. Adult and pediatric patients: • If using a standard Quadtrode electrode, place it slightly to the left of the patient’s sternum, with the top two electrodes on the breast line and the bottom two electrodes below the breast line. • If using a CV Quadtrode electrode, attempt to keep a small separation between individual electrodes—a distance that is wide enough to properly capture the ECG vector, but not so wide as to cause excessive noise pickup. (Increasing the loop area between electrodes has a negative effect on ECG quality unique to the MRI environment that causes more noise to be picked up by the ECG leads). Neonatal and infant patients: • Depending on the patient’s weight, center a standard Quadtrode electrode or a neonate Quadtrode electrode over the sternum and the breast line. Deviations from the guidelines for Quadtrode electrode placement can affect the produced ECG signal as follows: • Placements offset above the breast line: Increases the T‐wave amplitude and the susceptibility to static field (B0) effects. • Placements offset below the breast line: Decreases the T‐wave amplitude, increase the distance from the aortic valve, the susceptibility to static field (B0) effects and the ECG wave amplitude. • Placements closer to the sternum: Increases the ECG wave amplitude and also any respiration‐induced noise. • Placements farther from the sternum: Decreases the ECG wave amplitude and any respiration‐induced noise. Expression MR400 Instructions for Use Monitoring ECG 5‐7 The diagrams below illustrate Quadtrode electrode placement site(s) according to patient type, including the preferred Quadtrode electrode type and location for different patient body sizes. Selecting sites on adult female patients Average weight adult female* Overweight adult female* CV Quadtrode CV Quadtrode Preferred Preferred Standard Quadtrode Standard Quadtrode *Where grayed images indicate placement sites against the ribcage under the breast. 5‐8 Monitoring ECG Expression MR400 Instructions for Use Selecting sites on adult male patients Average weight adult male Overweight adult male* CV Quadtrode CV Quadtrode Preferred Standard Quadtrode Standard Quadtrode Preferred *Where the grayed image indicates a placement site against the ribcage under the breast. Expression MR400 Instructions for Use Monitoring ECG 5‐9 Selecting sites on pediatric patients 5‐10 Monitoring ECG Pediatric female Pediatric male CV Quadtrode CV Quadtrode Standard Quadtrode Standard Quadtrode Preferred Preferred Expression MR400 Instructions for Use Selecting sites on infants and neonatal patients Infants and Neonates Standard Quadtrode Neonatal Quadtrode Preparing the Quadtrode Electrode Site Proper preparation for the application of the Quadtrode electrode is critical to ECG performance. The result of poor application preparation will be poor ECG monitoring performance. If electrode contact with the skin is poor, then remove and discard the Quadtrode electrode, and repeat the site preparation process again according to the instructions below. Never reuse a Quadtrode electrode because it will not securely adhere to the skin. To prepare a Quadtrode electrode site on a patient Step Expression MR400 Instructions for Use Action Check the expiration date of the Quadtrode electrode package. Select the application area(s), avoiding the areola and nipple when possible, for the Quadtrode electrode site(s) as provided on page 5‐ 7. Monitoring ECG 5‐11 Step Action If necessary, shave the application area to remove hair from the selected Quadtrode electrode site(s). Apply ECG Skin Prep Gel (REF 989803152291) to a gauze pad. Briskly rub the selected site(s) with the gauze pad (the skin may turn pink). Remove any excess gel with a clean gauze pad. Place the Quadtrode electrode at the prepared site(s) on the patient. Notes • The ECG Skin Prep gel contains light abrasive pumice and saline that clean and enhance the conductive properties of the skin, thus enhancing ECG performance. This practice also helps remove ambient artifacts. • Isopropyl/rubbing alcohol must not be used to prep the site as it breaks down the conductive properties of the skin, thus degrading ECG performance. Attaching the ECG Lead Cable WARNINGS • Never use any ECG lead cables other than the specified ECG lead cables. • High levels of RF energy may cause patient heating or burns. • An ECG lead cable that becomes inadvertently looped during an MRI examination may act as conductive lines for RF induced currents, resulting in excessive heating and possible burns. When lead cables or other cables form a conductive loop in contact with the patient's tissue, minor to severe burning can result. Please refer to the additional information in Appendix E to prevent excessive heating associated with MRI procedures. Follow steps to minimize the risks of MRI-related heating on page 520. Given in relation to the patient’s limbs, designators and colors of the ECG lead cable clips reference connection locations on the Quadtrode electrode. Also, note that depending upon the lead cable version, AAMI (Association for the Advancement of Medical Instrumentation) or IEC (International Electrotechnical Commission), different designators and colors are used for these references. The diagrams below illustrate the lead cable attachment locations to the Quadtrode, according to the ECG lead cable version and limb. 5‐12 Monitoring ECG Expression MR400 Instructions for Use AAMI ECG Lead Cable Connections IEC ECG Lead Cable Connections AAMI ECG Lead Cable Clip Designator / Color IEC ECG Lead Cable Clip Designator and Color RA / White R / Red Right arm RL / Green N / Black Right leg LA / Black L / Yellow Left arm LL / Red F / Green Left leg Associated Limb CAUTION ECG lead cable clips should not be placed on the patient’s extremities. To attach the ECG lead cable to the wECG module and then to the Quadtrode electrode contacts Step Action Insert the connector of the ECG lead cable into the cable port on the wECG module. CAUTION When inserting or removing the lead cable, only use the connector as a finger-hold; never pull or apply excessive force to the wires. Expression MR400 Instructions for Use Monitoring ECG 5‐13 Step Action Depending upon the ECG lead cable type, attach the clips to the Quatrode electrode contacts, as shown in the appropriate connection diagram on page 5‐12. Squeeze each clip open then place the clip onto the electrode contact and release. CAUTION When inserting or removing the clip leads, use the clip as the fingerhold; never pull or apply excessive force to the wires. If using a standard Quadtrode electrode, secure the lead cable wires using the lead retainer. See page 5‐3 for the location. Check the battery indicators on the wECG module to ensure that enough charge exists in at least one of the installed batteries: • Green battery indicator = Charge sufficient; proceed to step 6. • Red battery indicator = Charge low; proceed to step 5. See page 2‐9 for details. (Also, you can reference the status information pane; see page 2‐16.) According to the red battery indicator(s) present on the wECG module, insert a charged module battery into the corresponding battery bay(s) and then recheck the battery indicator(s) to ensure a sufficient charge before proceeding; see page 1‐24. Check the network channel indicator on the wECG module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 8. • Flashing = No communication; proceed to step 7. See page 2‐10 for details. (Also, you can reference the status information pane; see page 2‐16.) An inoperative ECG parameter or wECG module is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm. 5‐14 Monitoring ECG Ensure that the wECG module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. Expression MR400 Instructions for Use Step Action Ensure that the ECG signal has the necessary amplitude by checking the displayed waveform; see Checking the ECG Signal Strength on page 5‐16. If Lead Fail is displayed, see page 5‐15 for troubleshooting details; or, if Lead Saturation is displayed, replace the Quadtrode electrode, see page 5‐11. Note During a Lead Fail condition, if the HR Source is set to ECG, then no HR measurement numeric will be displayed in the ECG and SPO2 VS boxes; see page 5-15 for an example. Keep the module outside the MR system bore by placing it in one of the two locations shown in Positioning the ECG Lead Cable and wECG Module for Scanning on page 5‐20. Lead Fail Indication Lead Fail (illustrated below) is an INOP alarm that will be displayed when the ECG trace can no longer be produced because one of the electrodes required for measurement is disconnected— either an electrode came off of the patient, an ECG lead cable clip came off of the electrode, or a wire in the ECG lead cable has failed. Depending upon the Trace A Lead (or Trace B Lead) setting (see page 5‐27), the electrode fault indicator(s), LL, LA, or RA, may be displayed in the ECG VS box (see the example below); see page 4‐31 for more information. WARNING Warning Failure to respond to a Lead Fail alarm will result in a lapse of patient monitoring. Expression MR400 Instructions for Use Lead Fail message indication Electrode fault indication, example Monitoring ECG 5‐15 Checking the ECG Signal Strength Evaluate the ECG signal produced by the patient before entry into the MRI scanner, the optimum time to correct any problem. A minimum signal strength should be present, as weaker signals may be prone to gradient interference: • Select Scale to adjust the displayed size of the waveform(s), where the scale indicator provides, a 1 millivolt (mV) reference at any given setting; see Selecting the Scale, below). Scale indicator QRS complex • Select Trace A Lead (or Trace B Lead) to adjust the configuration of the leads used for ECG signal detection, where the best signal strength is indicated by the displayed peak‐to‐peak amplitude of the QRS complex, which should be at least 1 mV (that is, the waveform should be equal to the size of the scale indicator). In some cases, a 1 mV ECG signal cannot be achieved due to patient physiology. In these cases, try to achieve the largest amplitude attainable. See Changing the Lead View, on page 5‐17. Selecting the Scale The Scale setting only changes how the ECG trace appears on the screen—increasing or decreasing the waveform and any artifacts. To increase the amplitude of the QRS complex, refer to Changing the Lead View on page 5‐17. To change the SCALE setting Step Action Ensure that the correct Patient Type has been selected; see page 3‐ 11 for details. Select the ECG VS box. The ECG menu appears. Current settings are displayed. Select Scale. The Scale menu appears; see page 5‐28. 5‐16 Monitoring ECG Expression MR400 Instructions for Use Step Action Select the setting. Only a setting of 5x or 10x is recommended. Auto 1x 5x 10x 15x 20x 25x 30x 40x The setting is applied. Take note of the scale indicator; see page 5‐22. If the selected scale results in an ECG trace so large that the waveform peaks are distorted or clipped, Overscale will be displayed. In this case, select another setting to resize the waveform until the message stops. Changing the Lead View If the QRS complex does not equal a minimum of 1 mV peak‐to‐peak, then complete the following steps to make the waveform amplitude increase. To change the lead view Step Action Verify that a Quadtrode electrode or Quadtrode electrodes are being used, and verify the expiration date, quality and packaging for the electrode. Ensure that the preferred Quadtrode electrode is being used; see page 5‐5. Ensure that the suggested placement site (or sites) is being used; see page 5‐7. Select the ECG VS box. The ECG menu appears. Current settings are displayed. Depending upon the trace being examined, select Trace A Lead or Trace B Lead. The respective menu appears. The current setting is highlighted. Expression MR400 Instructions for Use Monitoring ECG 5‐17 Step Action Select the desired lead view setting. II III AVL AVR AVF The setting is changed. Note When presented with poor gating or heart rate performance, it may be necessary to use the Pediatric ECG setting; see page 5-32. If the amplitude did not improve, repeat step 5 and cycle through the remaining lead view settings until a 1 mV signal amplitude is attained. If the amplitude did not improve, remove the ECG lead cable and the Quadtrode electrode. Then prep the application site again and apply a new Quadtrode electrode. Minimizing ECG Waveform Noise Noise can render an ECG waveform unusable, as shown in the example below. Many causes can result in a noisy ECG waveform, including: 5‐18 Monitoring ECG • Use of alcohol‐based products during patient prep. • Use of a Quadtrode electrode that is expired or dried‐out. • Use of wrong or damaged ECG cable leads. • Improper placement of the Quadtrode electrode. • Placing the MR400 inside the 5000 gauss line. • Placing the wECG module inside the bore. • MR vibrations affecting the wECG module. • Incorrect notch filter setting; see page 5‐22. Expression MR400 Instructions for Use • Selecting Monitor as the Filter Mode for the scan sequence; see page 5‐31. • Scan sequence parameters. • Improper connection of ECG lead cable to Quadtrode electrode contact locations. • Routing the ECG lead cable adjacent to the body coil or underneath an extremity coil. • Excessive distance between electrodes when using CV Quadtrode electrodes. Positioning the ECG Lead Cable and wECG Module for Scanning WARNINGS • When applying electrodes or connecting the ECG lead cable, ensure that the electrodes or connectors never contact other conductive materials including grounded conductors. In order to prevent contact with other conductors or earth ground, make sure all the electrodes or connectors are properly attached to the patient. • No other electrical conductors (e.g. wires, leads, probes, et cetera) should be placed within the MRI bore at the same time as the ECG lead wires. Electrode heating risk increases when multiple conductive cables and probes are placed in the bore with the patient. Mixing of conductors from various manufacturers (catheters, temperature sensors, et cetera) is not recommended. Multiple electrical conductors within the MRI bore can allow cross-coupling between these various conductors, and appear as a large antenna for RF energy pick-up, which will result in electrode heating, and possibly skin burns. It is always important to identify if the patient has any metallic wires, conductors, implants, stents, et cetera. within their body which will act as crosscoupling conductors. If these are present, ECG monitoring may not be able to be performed without experiencing electrode heating. Non-conductive tubes, air-lines, et cetera—including NIBP cuffs and hoses, EtCO2 and/or oxygen air-lines, and SpO2 probes—can be used safely as these items do not include electrically conductive materials. The MR400 has been validated for use with all accessories specified in the accessory list; see page 1-33. • Circular, U-shaped or S-shaped loops in the ECG lead cable should be avoided to reduce the risk of heating. • Do not use the Velcro storage strap to loop the ECG lead cable during MR scanning; otherwise, there is a risk of cable heating and possibly skin burns. Expression MR400 Instructions for Use Monitoring ECG 5‐19 Positioning the ECG lead cable Position and keep the ECG lead cables in a straight line. Never allow the ECG lead cables to touch the MR system bore. Any loop (circular, U‐shaped, S‐shaped) in the cables or cable contact with the MR system bore will cause heating in the cables or in the patient electrodes. Follow the steps below to minimize the cable heating risk. To minimize the risk of MRI‐related heating Step 5‐20 Monitoring ECG Action Arrange the ECG lead cable and the clip leads neatly, in a straight alignment, with no looping. Avoid contact between cables and bare skin. Cushion the wECG module. Use only the ECG lead cables designated for use with this product; see page 1‐ 35. Minimize the use of multiple cables. (See the warnings on page 5‐ 19 for details.) The wECG module, ECG lead cables and Quadtrode electrode are acceptable for use within MR systems with static magnetic field strengths of 3.0 Tesla or less within the MR system bore using a MR system reported whole body average Specific Absorption Rates (SAR) up to 4.0 W/kg. Ensure that B1rms < 7.2 μT. Monitoring of ECG at power levels of greater than a MR system reported, whole body averaged SAR of 4 W/kg is not recommended for the general patient population. Such monitoring must only be attempted with conscious patients with normal thermoregulatory capabilities so that they may warn you of possible excessive heat at the monitoring sites. Use caution for scan times (that is, per pulse sequence) greater than 15 minutes. For MRI scans with average SAR > 1 W/kg, limit scan time to 15 minutes and pause at least 3 minutes between scans to allow the ECG electrodes to cool. During measurement, check the patient to ensure that MRI‐related heating is not occurring. Expression MR400 Instructions for Use Positioning the wECG module WARNING Warning The wECG module must be kept outside the system bore or image distortion may result. This is a result of proton emissions from the ECG module. Depending upon your region of interest (ROI) and the largest field of view being examined (see illustration below), follow these guidelines to ensure the best performance of the wECG module, especially during harsh scan sequences: • For static field (B0) compliance, keep the module at least 28 cm (11 inches) outside the MRI field of view. • Considering the scan to be performed, place the module on or near the patient and as close to the bore iso‐center as possible. • Place the module as close to the bore opening as possible. (If the module can be placed outside the bore, positioning at the bore iso‐center is not necessary.) • Place the module on a cushioned surface to minimize MR vibrations. Male: ROI Magnet type: Achieva 3.0T XR Series Bore Iso-center Patient Table MRI Bore Male: Largest FOV (45 cm) Bore Iso-center Patient Table MRI Bore For B0 compliance always keep the wECG module 28 cm from the edge of the FOV. For example, a lower abdomen scan places the module at an acceptable distance of 30 cm (considering the length of the ECG cable) Expression MR400 Instructions for Use Monitoring ECG 5‐21 WARNING Warning If the wECG module is positioned incorrectly when used within the MR magnet room, the following factors may cause ECG waveform distortion and numeric inaccuracies: • Fast magnetic field changes usually found with, but not limited to, scan sequences using Peripheral Nerve Stimulation (PNS) levels above 80 percent. • Severe vibrations induced by scan sequences using PNS levels above 80 percent. • The distance from the bore iso-center in the x, y, or z directions. Selecting the Filter Mode Choose the appropriate ECG filter mode for your MRI study; see page 5‐31 for mode details. To change the filter mode setting Step Action Press the ECG Filter key. The Filter Mode menu appears. The current setting is highlighted. Select the desired filter. Monitor Default Advanced 1 Advanced 2 The setting is applied, as indicated in ECG VS box. ECG Waveforms and VS Box The ECG measurement is displayed as waveforms in the VS trace area of the screen and as numeric information in the ECG VS box. Other data, including ECG‐related alarm information, are also provided in this area of the screen, as detailed below. 5‐22 Monitoring ECG Expression MR400 Instructions for Use 1 16 15 14 13 12 Item Name Definition Is the ECG waveform (Trace A, when enabled) ECG VS waveform 11 10 Note To change the waveform speed, see Sweep Speed on page 3-25. Alarm flag area Displays ECG alarm flags when detected; see page 4-31. ECG VS box label Indicates the ECG vital sign parameter, and accesses the ECG menu Unit of measure Indicates that the heart rate numeric is given in BPM (beats per minute) Heart rate numeric Is the patient’s detected heart rate measurement Magnet indication Indicates Magnet Filter when engaged. HR upper alarm limit Is the upper limit setting for the heart rate alarm, and accesses the HR Alarm Limits menu HR lower alarm limit Is the lower limit setting for the heart rate alarm, and accesses the HR Alarm Limits menu HR source Indicates the source used to measure the heart rate 10 Filter mode Indicates the active ECG filter mode; see page 5-31. 11 Electrode fault indication Displays the electrode fault indicator(s) when a disconnected ECG lead or bad electrode is detected, where LL = left leg, LA = left arm, and RA = right arm; and, LL, LA, RA, = RL right leg or all leads Expression MR400 Instructions for Use Monitoring ECG 5‐23 Item Name Definition 12 Is the ECG waveform (Trace B, when enabled) ECG VS waveform Note To change the waveform speed, see Sweep Speed on page 3-25. 13 Scale indicator Represents a 1 millivolt signal amplitude for the selected scale of Trace B* 14 Lead type Is the selected ECG lead for Trace B 15 Lead type Is the selected ECG lead for Trace A 16 Scale indicator Represents a 1 millivolt signal amplitude for the selected scale of Trace A* * The displayed waveform should at least be equal to the size of this indicator, as signals with lower amplitudes may be prone to gradient interference; see Checking the ECG Signal Strength on page 5-16 for details. Changing the Heart Rate Alarm Limits The Heart Rate Alarm Limits menu can be accessed by touching the alarm limit settings in the ECG VS box. 9 10 11 12 13 14 15 16 7 6 5‐24 Monitoring ECG 4 3 Alarm limit settings, ECG VS box Extreme Tachycardia button High button Low button Extreme Bradycardia button HR Alarm Limits menu label Expression MR400 Instructions for Use 7 Enter button Current adjustment Extreme Bradycardia delta value 10 Extreme Bradycardia alarm setting 11 Alarm limit, minimum 12 Lower alarm limit setting 13 Upper alarm limit setting 14 Alarm limit, maximum 15 Extreme Tachycardia alarm setting 16 Extreme Tachycardia delta setting To change the heart rate alarm limit settings Step Action Select the alarm limit settings in the ECG VS box. The HR Alarm Limits menu appears. Current settings are displayed. Select the Low, High, ∆ ExtrBrady, or ∆ ExtrTachy button. The selected button will be highlighted and the current adjustment will be displayed. Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. Press the Enter button to save the setting. The alarm limit setting is updated. To change other alarm limit settings, repeat steps 2, 3, and 4. The current adjustment will reflect the change. Note See chapter 4 for detailed alarm limit setting instructions and options. Expression MR400 Instructions for Use Monitoring ECG 5‐25 ECG Menu ECG menu items allow you to control ECG traces, functions and settings. To open the ECG menu Select the ECG VS box. ECG menu ECG VS box The following ECG menu items are available:. 5‐26 Monitoring ECG Trace A Lead Trace B Lead Scale Gating Source HR Source HR Tone Source Filter Mode Extreme HR Pediatric ECG 10 T-Wave Suppression 10 Expression MR400 Instructions for Use To change settings in the ECG menu Step Action Select the ECG VS box. The ECG menu appears. Current settings are displayed. Select from the following ECG menu items: Trace A Lead Trace B Lead Scale Gating Source HR Source HR Tone Source Filter Mode Extreme HR Pediatric ECG T‐Wave Suppression The menu item appears. The current setting is highlighted. Select the desired setting from the menu options (except Extreme HR, Pediatric ECG and T‐Wave Suppression, which are selectable on the ECG menu). The setting is entered. To change other settings, repeat steps 2 and 3. Trace A Lead Sets the ECG A lead configuration (lead view). For best ECG and heart rate monitoring, always select the optimal lead view, the one that provides the least artifact and largest waveform detection. The following options are available: • Off • • II (Default) • III • AVL • AVR • AVF To set the ECG A lead Expression MR400 Instructions for Use Monitoring ECG 5‐27 See Changing the Lead View on page 5‐17. Trace B Lead Sets the ECG B lead configuration (lead view), allowing you to view two ECG waveforms simultaneously. The following options are available: • Off (Default) • • II • III • AVL • AVR • AVF To set the ECG B lead See Changing the Lead View on page 5‐17. Scale Sets the scale for the ECG waveforms. After making this setting, take note of the scale indicator (see page 5‐22). If the selected scale results in a waveform with distorted or clipped peaks, Overscale will be displayed and another setting should be selected until the message stops. The following options are available: • Auto makes the waveform fill the ECG trace area (not recommended for use in the MR). • 1x • 5x • 10x (Default) • 15x • 20x • 25x • 30x • 40x To set the ECG scale See Selecting the Scale on page 5‐16. 5‐28 Monitoring ECG Expression MR400 Instructions for Use Note Scale does not affect the signal analyzed by the MR400 for QRS detection and ECG gating. Gating Source Sets the cardiac gating source based on a measured signal that is used for MR system triggering. (This is the same option as in the SPO2 menu.) The following options are available: • ECG outputs a signal that represents the detection of the R‐peak of a QRS complex. (Default) • Pulse outputs a signal that represents the detection of the peak of the peripheral pulse complex. To set the gating source See Appendix D for details. Note Trace A is the default output channel for interfacing the cardiac gating input. To use Trace B, set Trace A to off, and ensure that Trace B is active (that is, not off); see page 5-28. HR Source Selects the source that produces the heart rate, as displayed in the ECG and SPO2 VS boxes (identical to and interactive with same option in the SPO2, P1 and P2 menus). The following options are available: • Auto sets the source automatically according to the highest priority active input that is first to report valid patient data. The priority ranking (highest to lowest) is ECG, P1, P2, SPO2 (provided that the P1 and P2 channels have been labeled ABP; see Set Label on page 8‐24 for details). The source will become unavailable when it has produced no valid data for a period of ten (10) or more seconds. The system examines the highest priority active input. If not found, the second‐highest priority input is chosen, et cetera. If none are present, then None is displayed as the heart rate measurement numeric. • ECG sets ECG as the source. (Default) • ABP sets ABP as the source (if no pressure channel is labeled ABP, a warning box will allow automatic renaming and selection before proceeding; also see Set Label on page 8‐24). Expression MR400 Instructions for Use Monitoring ECG 5‐29 • SPO2 sets SPO2 as the source. To set the heart rate source Step Action Select the ECG VS box. The ECG menu appears. Current settings are displayed. Select HR Source. The HR Source menu appears. The current setting is highlighted. Select the desired setting for the heart rate source: Auto ECG ABP SPO2 The source is changed. HR Tone Source Sets the source used for the heart rate tone (identical to and interactive with the same option in the Monitor Setup > Sound Adjust menu and in the SPO2 menu). The following options are available: • Off removes the heartbeat detected symbol from the display and sounds no pulse tone. (Default) • QRS provides the heartbeat detected symbol and a tone triggered by the QRS detection from the ECG vital sign. • SPO2 provides the heartbeat detected symbol and a tone modulated by the SPO2 vital sign, where the lower the SPO2 value, the lower the pitch. To control the heart rate tone source Step Action Select the ECG VS box. The ECG menu appears. Current settings are displayed. 5‐30 Monitoring ECG Expression MR400 Instructions for Use Step Action Select HR Tone Source. The HR Tone Source menu appears. The current setting is highlighted. Select the desired setting for the tone source: Off QRS SPO2 The setting is changed. Filter Mode Sets the filtering mode for the ECG signal. All filtering mode except Monitor utilize an adaptive filter scheme for removal of gradient artifacts generated by MR systems. Notes • Due to the variety of MRI sequence characteristics, if the filter recommendations below do not provide optimum performance in all cases, the selection may improve ECG performance during a specific scan sequence. • ECG performance can be affected by electrode placement, the MRI procedure, the image slice angle and slice thickness. In situations where ECG performance is not optimal, select the ECG lead view (I, II, III, AVL, AVR, or AVF) that provides the best performance; see page 5-17. • For cases not requiring cardiac gating, start with the Default filter (depending on the MRI sequence) then switch filters if a gradient artifact is noticed. If a gradient artifact is still present, check ECG signal strength and try lead I or III. The following options are available: • Monitor is a mode that provides filtering characteristics that meet the specification of the AAMI and IEC. This mode is useful during patient preparation, transporting, base‐lining, et cetera, but is not meant for use during active MRI sequences due to noise; see page 5‐18. • Default provides the best possible performance on 0.15 to 3.0T MR systems during Echo Train type MRI sequences. (Default) • Advanced 1 provides the best possible performance during cardiovascular (CV) MRI scans that involve steady‐state free precession imaging with balanced gradient (True‐FISP, FIESTA, or Balanced FFE) sequences on 1.5 and 3.0T MR systems. For cases requiring cardiac gating, start with the Cardiac filter in Lead II and switch filters if a gradient artifact is noticed. If gradient artifact is still present, check signal amplitude and try Lead I or III. Expression MR400 Instructions for Use Monitoring ECG 5‐31 • Advanced 2 provides the best possible performance on 1.5 and 3.0T MR systems for removal of gradient artifacts generated by MR systems during MRI sequences such as neurological and cardiovascular scans. To set the filter mode See Selecting the Filter Mode on page 5‐22. Extreme HR Controls the alarm function for Extreme Bradycardia (where a decrease in heart rate by a selectable value lower than the low HR limit setting will result in an alarm), and for Extreme Tachycardia (where an increase in heart rate by a selectable value higher than the high HR limit setting will result in an associated alarm). The following options are available: • Off does not report an extreme HR alarm event. • On reports an extreme HR alarm event when detected and displays the ∆ ExtrBrady button (for Extreme Bradycardia) and the ∆ ExtrTachy button (for Extreme Tachycardia) on the ECG Alarm Limits menu and the controls for the extreme HR alarm adjustments. (Default) To control the Extreme HR alarm function Step Action Select the ECG VS box. The ECG menu appears. Current settings are displayed. Locate Extreme HR and select the desired setting: Off On The setting is entered. Pediatric ECG Provides additional ECG filtering when patients, particularly pediatrics, present with narrow QRS complexes and/or high (120 BPM) heart rates. The following options are available: 5‐32 Monitoring ECG • Off does not apply the pediatric ECG filter. (Default) • On processes ECG data using a pediatric algorithm, in addition to the gradient filter setting (and when if the ECG trace is printed, PED ECG = ON or PED ECG = OFF will appear on the strip). Expression MR400 Instructions for Use Note If Patient Type is set to Neo then Pediatric ECG is set to On and locked. When Patient Type is changed to Adult, Pediatric ECG will be set to off and unlocked. Pediatric ECG Patient Type Condition Off Adult Unlocked On Pediatric Unlocked On Neonatal Locked To control pediatric ECG filtering Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. Locate Pediatric ECG and select the desired setting: Off On The setting is entered. T-Wave Suppression Allows you to reduce the T‐wave amplitude when extremely large due to the magnetohydrodynamic effect (MHD), which can prevent gating. Use for accurate gating when an unusually high T‐wave amplitude, relative to the R‐wave amplitude, is produced. The following options are available: • Off (Default) • On Note T-Wave Suppression is unavailable when Filter Mode is set to Monitor; see page 5-31. Expression MR400 Instructions for Use Monitoring ECG 5‐33 To control T‐wave suppression Step Action Select the ECG VS box. The ECG menu appears. Current settings are displayed. Locate T‐Wave Suppression and select the desired setting: Off On The setting is entered. 5‐34 Monitoring ECG Expression MR400 Instructions for Use CHAPTER 6 Monitoring SPO2 The pulse oximetry feature of the MR400 uses a motion‐tolerant signal processing algorithm based on Fourier Artifact Suppression Technology (FAST) and is calibrated to display oxygenated hemoglobin measurements, a visual pulse indication and a pulse rate, specifically: • Oxygen saturation of arterial blood (SPO2): The percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation). • Plethysmography (pleth) waveform: A visual indication of the patient’s pulsatile blood flow. • Pulse rate (as derived from the pleth waveform): The number of detected pulsations per minute. • Perfusion index value – A numerical indication of the pulsatile portion of the measured signal caused by arterial pulsation. CAUTION Before use, verify that the wSpO2 module is operating correctly and communicating by checking the displayed SPO2 numeric and waveform. Also, ensure that the wSpO2 module has a sufficiently charged battery by checking its displayed status symbol; see page 2-16. Note A pulse oximeter should be considered an early warning device. As a trend toward patient deoxygenation is indicated, blood samples must be analyzed by a laboratory co-oximeter to understand the patient’s condition completely. wSpO2 Module, SpO2 Probe and SpO2 Attachment The wSpO2 module, SpO2 probe and SpO2 attachment (clip or grip) are intended for patient uses when non‐invasive arterial oxygen saturation, pulse rate monitoring or pulse gating are required. The wSpO2 module, SpO2 probe and SpO2 attachment may not be used within the MR system bore. Expression MR400 Instructions for Use Monitoring SPO2 6‐1 WARNING Philips has verified the compatibility of the monitor, probe, and cable specified in the Accessory List. The user should verify that only Philips accessories specified in the Accessory List are used. Otherwise, patient injury can result. CAUTION If dropped, the wSpO2 module must be verified for correct operation before use; see page 14-12. Note Refer to your facility's biohazard procedure for disposal of SPO2 attachments and probes when they become unusable. Usually probes are disposed of as medical waste per facility procedures. Patient Preparation for SpO2 Monitoring When monitoring SpO2, the SpO2 attachment, the site selected on the patient, the SpO2 attachment’s position on the patient, and the ambient environment will impact the performance and operation of the parameter. Selecting the Site and SpO2 Attachment When applying the clips or grips to the patient, site preparation and the pressure and alignment of the SpO2 attachment are important factors to consider. Select the most appropriate limb that best fits the attachment’s size. For measurements to be accurate and reliable, the optimum fit is reached when the fiber head windows on the attachment oppose each other while covering skin or nail. Refer to the instructions provided with the SpO2 attachment when selecting and connecting the clip or grip. 6‐2 Monitoring SPO2 Expression MR400 Instructions for Use Attaching the Clip or Grip to the SpO2 Probe To attach a clip (or grip) to the SpO2 probe Carefully snap the fiber heads on the SpO2 probe into the receptacles (windows) on the SpO2 attachment (clip or grip). Either fiber head can be inserted into either window on a clip or grip. SpO2 probe SpO2 attachment (clip shown) Fiber heads Applying the SpO2 Attachment to the Patient Read the warnings before applying an SPO2 attachment to the patient. WARNINGS • General fit: If a clip or grip is too loose, it might compromise the optimal alignment or dislocate. If the clip or grip is too tight (for example, if the application site is too large or becomes large due to edema), excessive pressure may be applied resulting in venous congestion distal from the application site, which could lead to interstitial edema, hypoxemia, tissue malnutrition, and inaccurate measurements. Skin irritations may occur as a result of the clip or grip being attached to one location for too long. Periodically inspect the clip or grip application site and change the application site at least every 4 hours. Exercise care when using tape to secure the clip or grip, as the stretch memory properties of most tapes can apply unintended pressure to the site easily. • Extremities to avoid: Avoid placing the clip or grip on extremities with an arterial catheter, intravascular venous infusion line, or inflated blood pressure cuff. Failure to do so may result in inaccurate readings or false alarm indications. • Protect the probe from contact with any liquid. If the probe, clips or grips show signs of damage like exposed fibers, replace the part immediately. Do not use damaged equipment. • Keep detached grips and clips away from small children to avoid possibility of swallowing. Expression MR400 Instructions for Use Monitoring SPO2 6‐3 To apply a reusable SpO2 clip to the patient Step Action Select the application site. It should match the SpO2 clip size so that the attachment does not fall off or apply excessive pressure at the site. If present, remove any colored nail polish from the application site. Press the clip to open. Push the clip over a finger so either fiber head is on the top over the root of the nail and the other fiber head opposite to it. Ensure that the finger is touching the stop at the cushion and lays nicely centered in the clip. To apply a disposable SpO2 grip (all, except neonate) to the patient Step 6‐4 Monitoring SPO2 Action Select the application site. It should match the SpO2 grip size so that the attachment does not fall off or apply excessive pressure at the site. If present, remove any colored nail polish from the application site. Lift off the release liners that protect the adhesive. Put the finger (or toe) onto either side of the attachment ‐ they are symmetrical ‐ such that the tip covers the window completely and does not protrude over the hinge. Close the grip. If the fit is good, press the attachment firmly on the finger or toe. If the fit is not good, reposition the attachment. Make sure the limb is centered nicely in the attachment. Wrap the foam wings around the fin‐ ger and attachment and stick to the opposing grip side. Do not stretch the foam to apply excessive pressure. Expression MR400 Instructions for Use To apply a disposable neonate SpO2 grip to the patient Step Action Select the application site. It should match the SpO2 grip size so that the attachment does not fall off or apply excessive pressure at the site. Lift off the release liners that protect the adhesive. Proceed according to the application site: • Foot application: Align the hinge on the outside facing ridge of the foot. Make sure the attachment is as far as possible to‐ ward the small toe but not over it. • Hand/Wrist application: Align the hinge on the outside fac‐ ing ridge of the hand or wrist. You may have to swivel the fi‐ ber heads to an optimal position to ease the application. With the hinge aligned with the ridge of the foot/hand/wrist, press one side to the skin and then wrap the other side around the limb pulling the long foam piece gently. Press both fiber heads gently to attach the adhesives. Secure the longer foam piece by pressing it firmly to the foam/ adhesive of the opposing side. Ensure that the two fiber heads are opposing and have good skin contact. The angle between the two fiber heads should be as small as possible, not exceeding 45°. If the attachment opens too much, reattach or try another site. WARNING Disposable SpO2 attachments are designed for single patient use and must be disposed after use. They must not be cleaned and reused. Follow your hospital’s guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. Expression MR400 Instructions for Use Monitoring SPO2 6‐5 Perfusion Index Value When enabled, the displayed perfusion index value (see page 6‐8) is an indication of the pulsatile portion of the SpO2 signal caused by the patient's arterial blood flow. If you need an indication of change in pulse volume, use perfusion index value. This value can also be used as a quality indicator of the SpO2 measurement from the module. The table below provides general guidelines regarding this index value. Perfusion Index Value Meaning Above 1.0 Optimal – high quality readings 0.3 to 1.0 Acceptable – good quality readings Below 0.3 Marginal – Attachment position should be adjusted or another site should be used. Note If a Low Perf alarm is generated, see page 4-32 for corrective actions. Positioning the wSpO2 Module for Scanning WARNING The wSpO2 module must be kept outside the MR system bore or image distortion may result. To ensure the best performance, specific positioning considerations are required when using the wSpO2 module in the MR magnet room, including during harsh scan sequences with peripheral nerve stimulation levels above 80 percent. While considering the scan to be performed: 6‐6 Monitoring SPO2 • Place the wSpO2 module on or near the patient and as close as possible to the bore opening; • Keep the SpO2 probe and wSpO2 module outside the MR system bore; • Place the wSpO2 module on a cushioned surface to minimize MR vibrations; and, • Cover the SpO2 attachment site on the patient with opaque material. Expression MR400 Instructions for Use WARNING If the wSpO2 module is incorrectly positioned when used within the MR magnet room, the following factors can cause SPO2 waveform distortion and numeric inaccuracies, and respiration numeric inaccuracies: • Fast magnetic field changes usually found but not limited to scan sequences using PNS levels above 80 percent. • Severe vibrations induced by scan sequences using PNS levels above 80 percent. • Distance from the bore opening. • Distance from the bore iso-center in the x, y, or z direction. To ensure best performance during SPO2 measurements Step Action Ensure that the fiber heads are directly opposite each other, as the light must pass through the patient’s tissue and be received for proper operation. Swivel each fiber head into a position that causes the least bending of the cable while providing the most comfort to the patient. Check the battery indicator on the wSpO2 module to ensure that enough charge exists: • Green battery indicator = Charge sufficient; proceed to step 5. • Red battery indicator = Charge low; proceed to step 4. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Insert a charged module battery into the wSpO2 module and then recheck the battery indicator to ensure a sufficient charge before proceeding; see page 1‐26. Check the network channel indicator on the wSpO2 module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 7. • Flashing = No communication; proceed to step 6. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Expression MR400 Instructions for Use Ensure that the wSpO2 module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. Check the perfusion index value for the quality of the SpO2 measurement from the module; see page 6‐6 for details. Monitoring SPO2 6‐7 Step Action Select the Patient Type. See Selecting the Patient Type on page 3‐11. Check for any displayed SPO2 messages If a message is present, follow the recommended action to achieve better results (see page 4‐26). 10 Place the module as close as possible to the bore opening. (If the module can be placed outside the bore, positioning at the iso‐ center is not necessary.) 11 Keep the SpO2 probe and module outside the MR system bore. 12 Place the module on a cushioned surface. 13 Cover the patient SpO2 attachment site with opaque material. 14 During measurement, check the patient to ensure that the application site has a pulsatile flow and that the site has not changed in thickness (for example, due to edema) causing an improper fit. SPO2 Waveform and VS Box The SpO2 measurements are displayed as a waveform in the VS trace area of the screen and as numeric information in the SPO2 VS box. Other data, including SpO2‐related alarm information, are also provided in this area of the screen, as detailed below. 6‐8 Monitoring SPO2 Expression MR400 Instructions for Use Item Name Definition Is the detected SpO2 (pleth) pulsatile waveform (Trace C), automatically adjusted for proper viewing if above a minimum level SpO2 VS waveform Note To change the waveform speed, see Sweep Speed on page 3-25. Alarm flag area Displays SPO2 alarm flags when detected; see page 4-31. SPO2 VS box label Indicates the SpO2 vital sign parameter, and accesses the SPO2 menu Heart rate numeric Is the patient’s detected heart rate measurement Unit of measure Indicates that the heart rate numeric is given in BPM (beats per minute) SpO2 upper alarm limit Is the upper limit setting for the SpO2 alarm, and accesses the SPO2 Alarm Limits menu SpO2 lower alarm limit Is the lower limit setting for the SpO2 alarm, and accesses the SPO2 Alarm Limits menu SpO2 numeric Is the patient’s detected arterial oxygen saturation measurement, given as a percentage Perfusion index Is the value for the portion of the measured signal caused by the pulsating arterial blood flow, which can be used as a measurement quality indicator; see page 6-15 Assessing Suspicious SPO2 Readings Pulse oximetry measurements are statistically distributed. With newer algorithms, such as FAST‐ SPO2, the calculation of SPO2 is not directly linked to the correct detection of each pulse. When the pulse rate is very low or a strong arrhythmia is present, the SPO2/plethysmography pulse rate may differ from the heart rate calculated from ECG. This does not indicate an inaccurate SPO2 value. If you doubt the measured SPO2, use the plethysmography wave to assess the signal quality. WARNING Always shield (for example, cover with opaque material) the SPO2 clip or grip from extraneous incidental light sources, as such light can cause erroneous SPO2 readings or pulse detection errors. Expression MR400 Instructions for Use Monitoring SPO2 6‐9 WARNINGS • SPO2 monitoring requires the detection of valid pulses to correctly determine SPO2 and heart rate values. Any of the following items can lead to inaccuracies of the SPO2 readings and/or prolonged measurement time: Ambient light (including photodynamic therapy), physical movement (patient and imposed motion), arrhythmias and/or erratic heartbeats, diagnostic testing, electromagnetic interference, electrosurgical units, dysfunctional hemoglobin, intravascular dyes, presence of dyes or pigments at the application site, and inappropriate positioning of the pulse oximeter attachment. If questionable readings are obtained, check the patient’s vital signs by alternate means before administering medication. • Attachment movement, ambient light (especially strobe or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the probe is not attached to a patient. Bandage and grip attachment designs are particularly sensitive to minimal movement that might occur when the probe is dangling, not attached to the patient. An unapplied probe may cause readings to be displayed on the monitor. To avoid misdiagnosis, ensure the probe is applied to patient correctly. Changing the SPO2 Waveform Amplitude The vertical scale of the displayed SPO2 waveform can be changed to best suit the viewing requirements. To change the SPO2 waveform amplitude Step Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. Select Size. The Size menu appears. The current setting is highlighted. Select the desired size: 10% 20% 40% 60% 80% 100% The setting is changed. 6‐10 Monitoring SPO2 Expression MR400 Instructions for Use Changing the SPO2 Alarm Limits The SPO2 Alarm Limits menu can be accessed by touching the alarm limit settings in the SPO2 VS box. 8 9 10 11 12 6 5 Alarm limit settings, SPO2 VS box High button Low button Desat button SPO2 Alarm Limits menu label Enter button Current adjustment Desat alarm setting Alarm limit, minimum 10 Lower alarm limit setting 11 Upper alarm limit setting 12 Alarm limit, maximum To change the SPO2 alarm limit settings Step Action Select the alarm limit settings in the SPO2 VS box. The SPO2 Alarm Limits menu appears. Current settings are displayed. Select the Low, High, or Desat button. The selected button will be highlighted and the current adjustment will be displayed. (Desat must be on; see page 6‐15.) Expression MR400 Instructions for Use Monitoring SPO2 6‐11 Step Action Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. Press the Enter button to save the setting. The alarm limit setting is updated. To change other limit settings, repeat steps 2, 3, and 4. The current adjustment will reflect the change. Note See chapter 4 for detailed alarm limit setting instructions and options. SPO2 Menu SPO2 menu items allow you to control SPO2 functions and settings. To open the SPO2 menu Select the SPO2 VS box. SPO2 menu SPO2 VS box 6‐12 Monitoring SPO2 Expression MR400 Instructions for Use The following SPO2 menu items are available: Size Averaging Time Perfusion Index Gating Source Desat Desat Time HR Source HR Tone Source To change settings in the SPO2 menu Step Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. Touch the menu item to select one of the following SPO2 options: Size Averaging Time Perfusion Index Gating Source Desat Desat Time HR Source HR Tone Source The menu item appears. The current setting is highlighted. Select the desired setting from the menu options (except Perfusion Index and Desat, which are selectable on the SPO2 menu). The setting is entered. To change other settings, repeat steps 2 and 3. Size Changes the vertical scale of the SPO2 (pleth) waveform so that high amplitudes can be scaled down to avoid clipping of the peaks and low amplitudes can be scaled up to view the peaks. The following options are available: Expression MR400 Instructions for Use Monitoring SPO2 6‐13 • 10% • 20% • 40% • 60% • 80% • 100% (Default) To adjust the size of the SPO2 waveform See Changing the SPO2 Waveform Amplitude on page 6‐10. Averaging Time Selects how quickly the reading responds to changes in the patient’s saturation, where selecting a longer duration will prevent the saturation value from changing quickly which can be useful for avoiding alarm triggering in patients with very dynamic conditions such as neonatal and pediatrics. The following options (in seconds) are available: • 5 Sec • 10 Sec (Default) • 15 Sec To set the averaging time of the SPO2 reading Step Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. Select Averaging Time. The Averaging Time menu appears. The current setting is highlighted. Select the desired time for averaging: 5 Sec 10 Sec 15 Sec The setting is changed. 6‐14 Monitoring SPO2 Expression MR400 Instructions for Use Perfusion Index Controls the perfusion index value indication and alarm function (see page 5‐6). The following options are available: • Off disables the perfusion index functions. • On enables the perfusion index functions. (Default) To control the perfusion index functions Step Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. Locate Perfusion Index and select the desired setting: Off On The setting is entered. Gating Source Sets the cardiac gating source based on a measured signal that is used for MR system triggering. (This is the same option as in the ECG menu.) The following options are available: • ECG outputs a signal that represents the detection of the R‐peak of a QRS complex. (Default) • Pulse outputs a signal that represents the detection of the peak of the peripheral pulse complex. To set the gating source See Appendix D for details. Desat Controls the desaturation alarm and allows adjustment of the Desat alarm setting (see page 6‐ 11), where a Desat alarm will be declared when the detected oxygenation condition has remained at or below the value for the period established by the Desat Time setting (see page 6‐ 16). The following options are available: • Off disables the desat alarm function. Expression MR400 Instructions for Use Monitoring SPO2 6‐15 • On enables the desat alarm function. (Default) To control the desat alarm function Step Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. Locate Desat and select the desired setting: Off On The setting is entered. Desat Time When Desat is on, this sets the time that must pass before declaring that a desaturation condition exists. The following options (in seconds) are available: • 20 Sec (Default) • 25 Sec • 30 Sec • 35 Sec • 40 Sec To set the desat time Step Action Ensure that Desat is On. Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. (See page 6‐15 for details.) 6‐16 Monitoring SPO2 Expression MR400 Instructions for Use Step Action Select Desat Time. The Desat Time menu appears. The current setting is highlighted. Select the desired time (in seconds) for the alarm indication: 20 Sec 25 Sec 30 Sec 35 Sec 40 Sec The setting is changed. HR Source Selects the source that produces the heart rate, as displayed in the ECG and SPO2 VS boxes (identical to and interactive with same option in the ECG, P1 and P2 menus). The following options are available: • Auto sets the source automatically according to the highest priority active input that is first to report valid patient data. The priority ranking (highest to lowest) is ECG, P1, P2, SPO2 (provided that the P1 and P2 channels have been labeled ABP; see Set Label on page 8‐24 for details). The source will become unavailable when it has produced no valid data for a period of ten (10) or more seconds. The system examines the highest priority active input. If not found, the second‐highest priority input is chosen, et cetera. If none are present, then None is displayed as the heart rate measurement numeric. • ECG sets ECG as the source. (Default) • ABP sets ABP as the source (if no pressure channel is labeled ABP, a warning box will allow automatic renaming and selection before proceeding; also see Set Label on page 8‐24). • SPO2 sets SPO2 as the source. To set the heart rate source Step Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. Select HR Source. The HR Source menu appears. The current setting is highlighted. Expression MR400 Instructions for Use Monitoring SPO2 6‐17 Step Action Select the desired setting for the heart rate source: Auto ECG ABP SPO2 The source is changed. HR Tone Source Sets the source used for the heart rate tone (identical to and interactive with same option in the in the Monitor Setup > Sound Adjust menu and in the ECG menu). The following options are available: • Off removes the heartbeat detected symbol from the display and no pulse tone will be sounded. (Default) • QRS provides the heartbeat detected symbol and a tone triggered by the QRS detection from the ECG vital sign. • SPO2 provides the heartbeat detected symbol and a tone modulated by the SPO2 vital sign, where the lower the SPO2 value, the lower the pitch. To control the heart rate tone source Step Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. Select HR Tone Source. The HR Tone Source menu appears. The current setting is highlighted. Select the desired setting for the tone source: Off QRS SPO2 The setting is changed. 6‐18 Monitoring SPO2 Expression MR400 Instructions for Use CHAPTER 7 Monitoring CO2 (LoFlo Option) When equipped with the LoFlo CO2 option, the patient’s airway respiratory gas can be monitored. The system uses sidestream measurements to produce: • A fractional inspired CO2 (FiCO2) value (the lowest reading of the CO2 waveform in the previous 20 seconds) and an end‐tidal CO2 (EtCO2) value measured during expiration. • A respiration rate: The number of breaths per minute. • A waveform of the concentration of carbon dioxide in the respiratory gases. WARNINGS • Do not use on patients that cannot tolerate the withdrawal of 50ml/min ± 10 ml/min from the airway or patients that cannot tolerate the added dead space to the airway. • An alarm will sound when the MR400 is too close to the MR magnet and shutdown of CO2 monitoring will occur. Always position the MR400 as indicated on page 3-2. Note LoFlo option-equipped models do not feature a water trap (see page 7-4). If your MR400 is equipped with a water trap, refer to chapter 9 for CO2 monitoring instructions. MR400 Preparation for CO2 Monitoring When preparing the MR400 for CO2 monitoring, ensure that the waste gas port (see page 1‐19) has been connected to your facility’s gas scavenging system for disposal of sampled and calibration gases. Note Never route the waste gas tubing in a location that will allow it to be an obstruction or stepped on. Expression MR400 Instructions for Use Monitoring CO2 (LoFlo Option) 7‐1 Operation and Use When monitoring anesthetic agent gases, the typical operations and possible conditions that can arise may result in potential messages requiring your attention. See page 4‐26 for a message listing and suggested actions. Warm-Up Period In order to achieve accurate identifications and measurements, the LoFlo system requires a warm‐up period to thermally stabilize. This warm‐up period begins when the CO2 parameter is activated. Upon activation, CO2 Warming Up will be displayed until the LoFlo system becomes fully operational (about 2 minutes). Zero Reference Adjustment WARNING During Zero calibration the system pulls ambient air through the zero intake port on the cart The calibration system assumes that the ambient air will contain normal trace amounts of CO2. If the system is placed in an unventilated area that allows CO2 (from the waste gas port on the rear panel, if not connected to a gas scavenging system) to accumulate, the result could be inaccurate CO2 zeroing and resulting inaccurate patient readings. Always place the cart in a well ventilated area. The LoFlo system will occasionally perform a zero reference adjustment (Zero Cal) to ensure the accuracy of the displayed gas concentrations. Performing CO2 Zero will be displayed during a zero reference adjustment; allow the process to complete. The maximum time required for calibration is approximately 40 seconds. Zero Cal is not required when switching sampling lines. Under certain conditions, Zero Cal will not be allowed: • If less than 20 seconds have passed since detection of the last breath; • If the CO2 temperature is unstable; or • If the sampling line is disconnected from the CO2 port. To perform a manual zero reference adjustment Step 7‐2 Monitoring CO2 (LoFlo Option) Action If CO2 Warming Up is displayed, wait as the system thermally stabilizes. When the message is cleared, proceed. Expression MR400 Instructions for Use Step Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. Select Zero Cal. Calibration will begin and Performing CO2 Zero will be displayed. When complete, the message will be removed. Breath Rate Distortion The effect of rise time distortion to the gas curve becomes apparent when the breathing rate increases so that the time for a full inspiratory or expiratory event gets shorter. In those situations, due to the effect of the rise time, the gas curve does not reach the true end‐tidal (or first inspired value) and the end‐tidal gas value may then be underestimated. Correspondingly, the first inspired value may be overestimated. Below is an exaggerated illustration of the effect. - - at gas sampling site — as presented by gas analyzer Et error Percent Fi error Time The breath rate limit for accurately resolved end‐tidal gas values (at an I:E ratio of 1:1) may be found in Appendix A. The effect of other I:E ratios may be calculated by determining the length of the shortest inspiratory/expiratory event that can be resolved accurately: tresolved = 60 / (2 x BRlimit(1:1) BRlimit(I:E) = 60 / ((I + E) x tresolved) The difference in these results when compared to the rise time's specification is that rise time's only tests 10‐90% performance. This specification is for (0 + accuracy) to (100 ‐ accuracy) % and is thus much tougher. The ability to properly resolve end‐tidal values can be measured by using the set‐up described in ISO 80601‐2‐ 55:2011 figure 201.101. In short, the method consists of sampling gas from two different sources connected to an electrically controlled pneumatic valve to permit rapid switching between the two sources. During the test, the valve is set to switch gas source at a number of frequencies (simulating the range of specified breath rates) and for each frequency the end‐tidal value presented by the gas analyzer is noted. From a diagram of end‐tidal value over frequency, the frequency at which the gas analyzer is no longer able to resolve end‐ tidal values according to specification is identified. This ability to properly resolve end‐tidal values is listed in the specification. Expression MR400 Instructions for Use Monitoring CO2 (LoFlo Option) 7‐3 Patient Preparation for CO2 Monitoring When preparing a patient, the accessory position on the patient will impact the performance and operation of the CO2 parameter. Selecting the CO2 Accessory In patients on a breathing circuit, a sample of the respiratory gas is drawn from the patient’s breathing circuit through an airway adapter and a gas sampling line. In patients who are not on a breathing circuit, the gas sample is drawn through a nasal cannula. These specially designed cannulas and on‐airway adapters incorporate a filter and sample cell to provide maximum filtration of fluids and contaminants to protect against system intake. When selecting CO2 accessories (see page 1‐34 for a listing), consider the following: • The type of patient (adult, pediatric, or neonatal) • Whether the patient is receiving supplemental oxygen • The condition of the patient • All accessories are single use. Connecting the Sampling Line To connect the sampling line Step Action Insert the sampling line connector into the CO2 port on the patient connection panel and then push the connector forward until you feel or hear it click into place. CO2 port Sampling line connector 7‐4 Monitoring CO2 (LoFlo Option) Expression MR400 Instructions for Use 2 If CO2 Warming Up is displayed, wait as the system thermally stabilizes (about 2 minutes). When the message is cleared, proceed. Always remove the patient sampling line from the CO2 port when not in use. (To remove the sampling line, press down on the locking tab and pull the connector from the port.) Note To increase the life of the filter and pump, when CO2 will not be used to monitor a patient, we recommend turning the CO2 parameter off; see Parameters on page 3-18. WARNINGS • Inspect CO2 port and accessories before use. If the sampling line, connector or port show signs of damage, replace the part immediately or discontinue use and contact technical support. Never use damaged equipment. • Frequently inspect the patient sampling line and keep it clear of any moving mechanisms (for example, table wheels) which could cut, pinch, or dislodge the sampling line. Leaks, reduced or stopped flow, or internal venting of sampled gas into damaged tubing will cause inaccurate measurements. • Do not position the sampling line in any manner that may cause entanglement or strangulation. • Replace the sampling line if excessive secretions are observed, as inaccurate measurements could result if the flow is reduced or stopped. • Leakages in the breathing system or sampling system may cause the displayed EtCO2 values to be too low. Always connect all components securely and check for leaks according to standard clinical procedures. Displacement of the sampling line cannula or airway adapter can cause lower than actual EtCO2 readings. • If CO2 values for patients who are not on a breathing circuit appear extremely low, check whether the patient is breathing through the mouth or whether one nostril is blocked. Notes • For optimum fit and compatibility, use only specified parts. • Always inspect the patient sampling line after attachment to the MR400. Expression MR400 Instructions for Use Monitoring CO2 (LoFlo Option) 7‐5 Applying the Sampling Line to the Patient Select the patient sampling line that is appropriate for the patient size and application. Patient sampling lines with the airway adapter are intended for use with breathing circuits and anesthesia circuits that have an integrated airway adapter. WARNING Patient sampling lines are intended for single-patient use only. Do not clean or disinfect these items. Follow your hospital’s guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. CAUTIONS • The accuracy of the data is greatly influenced by the proper use and fitting of the patient sampling line to ensure proper sampling without the introduction of outside air. • Remove the patient sampling line from the CO2 port when not in use. To apply the sampling line to the patient Step 7‐6 Monitoring CO2 (LoFlo Option) Action Ensure that the sampling line is clean, dry and undamaged. Replace the line if necessary. Insert the sampling line connector into the CO2 port (see page 7‐4). A click will be heard when properly inserted. Position the cannula on the patient’s face by inserting the nasal prongs into the nostrils. Pass the tubing over the ears and behind the head, ensuring the patient’s head will not rest on any part of the cannula while the patient is lying down. Slide the sleeve toward the patient’s head to assure a good fit of the cannula. If using the sampling line with the airway adapter, proceed to step 7; otherwise go to step 8. Expression MR400 Instructions for Use Step Action Place the airway adapter at the proximal end of the airway circuit. CAUTION Always insert the patient sampling line into the CO2 port before inserting the airway adapter into the breathing circuit. Failure to follow this may introduce a leak in the circuit, thereby reducing set minute volume. Note Do not place the airway adapter between the ET tube and the elbow as this may allow patient secretions to accumulate in the adapter. If pooling does occur, replace the airway adapter. To prevent moisture from draining into the airway adapter, always place the adapter tubing in a up position, as shown above. Select the Patient Type. See Selecting the Patient Type on page 3‐11. Check that the connections have been made correctly by verifying the patient’s breathing efforts with the displayed waveform. WARNING Before completion of patient setup, ensure that the patient’s breathing efforts coincide with the displayed CO2 waveform. 10 If the following warning is displayed: Persistent CO2 occlusion detected. Please clear occlusion and press OK to resume using CO2 Clear any pinches or obstructions in the sampling line before proceeding. CO2 Waveform and VS Box The CO2 measurement is displayed as a waveform in the VS trace area of the screen and as numeric information in the CO2 VS box. Other data, including CO2‐related alarm information, are Expression MR400 Instructions for Use Monitoring CO2 (LoFlo Option) 7‐7 also provided in this area of the screen. (CO2 [RESP] information can be displayed in the CO2 VS box or in the RESP VS box, as detailed below.) 3 4 5 10 12 Item Name Definition Is the detected CO2 waveform (Trace D) CO2 VS waveform 11 Note To change the waveform speed, see Resp Speed on page 3-25. Alarm flag area Displays CO2 alarm flags when detected; see page 4-31. CO2 VS box label Indicates the CO2 vital sign parameter, and accesses the CO2 menu Unit of measure Indicates that the gas measurement numeric values are given in mmHg (millimeters of mercury) or kPa (kilopascals); see page 7-11. FiCO2 numeric Is the patient’s detected fractional inspired CO2 measurement EtCO2 numeric Is the patient’s detected end-tidal CO2 measurement EtCO2 upper alarm limit Is the upper limit setting for the end-tidal CO2 alarm, and accesses the CO2 (Et) Alarm Limits menu EtCO2 lower alarm limit Is the lower limit setting for the end-tidal CO2 alarm, and accesses the CO2 (Et) Alarm Limits menu Respiration rate upper alarm limit Is the upper limit setting for CO2-derived respiration rate alarm, and accesses the CO2 (RESP) Alarm Limits menu 10 Respiration rate lower alarm limit Is the lower limit setting for CO2-derived respiration rate alarm, and accesses the CO2 (RESP) Alarm Limits menu 11 Respiration rate numeric Is the patient’s detected respiration rate measurement, as derived from CO2 12 Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) When Source is set to BEL in the RESP menu (see page 10-5), the CO2 VS box will also contain CO2-derived respiration rate elements, as indicated by the shaded rows and illustration above; otherwise, this information will be displayed in the RESP VS box (see page 7-10). 7‐8 Monitoring CO2 (LoFlo Option) Expression MR400 Instructions for Use Changing the CO2 and CO2 (RESP) Alarm Limits The CO2 (Et) and CO2 (Fi) Alarm Limits menu can be accessed by touching the alarm limit settings in the CO2 VS box. 8 9 10 11 6 5 4 3 2 Alarm limit settings, CO2 (Et), CO2 VS box High button Low button CO2 (Et) Alarm Limits menu label (active adjustment shown) CO2 (Fi) Alarm Limits menu label Enter button Current adjustment Alarm limit, minimum Lower alarm limit setting 10 Upper alarm limit setting 11 Alarm limit, maximum To change the CO2 (Et) and CO2 (Fi) alarm limit settings Step Action Select the (Et) CO2 alarm limit settings in the CO2 VS box. The CO2 Alarm Limits menu appears. Current CO2 (Et) settings are displayed. Select the CO2 alarm limits menu, CO2 (Et) or CO2 (Fi), that you want to change. The associated menu appears. Current settings are displayed. Expression MR400 Instructions for Use Monitoring CO2 (LoFlo Option) 7‐9 Step Action Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining settings, repeat steps 2–5. The current adjustment will reflect the change. At the default setting, the CO2 (RESP) Alarm Limits menu can be accessed by touching the alarm limit settings in the RESP VS box. 7 8 10 High button Low button Alarm limit settings, CO2 (RESP), RESP VS box CO2 (RESP) Alarm Limits menu label Enter button Current adjustment Lower alarm limit setting Alarm limit, minimum Upper alarm limit setting 10 7‐10 Monitoring CO2 (LoFlo Option) Alarm limit, maximum Expression MR400 Instructions for Use To change the CO2 (RESP) alarm limit settings Step Action Select the CO2 (RESP) alarm limit settings in the RESP VS box (or, in the CO2 VS box, see page 7‐7.) The CO2 (RESP) Alarm Limits menu appears. Current settings are displayed. Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining setting, repeat steps 2, 3, and 4. The current adjustment will reflect the change. Note See chapter 4 for detailed alarm limit setting instructions and options. Changing the Unit of Measure To change the unit of measure Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) sub‐menu appears. On the Service(Bio‐Med) menu, select System Config. The System Config menu appears. Current settings are displayed. Expression MR400 Instructions for Use Monitoring CO2 (LoFlo Option) 7‐11 Step Action On the System Config menu, select Gas Units. The Gas Units menu appears. The current setting is highlighted. Select the desired unit of measure: mmHg kPa The setting is changed. CO2 Menu The CO2 menu allows you to control the CO2 and CO2 (RESP) monitoring functions and settings. To open the CO2 menu Select the CO2 VS box. CO2 menu CO2 VS box 7‐12 Monitoring CO2 (LoFlo Option) Expression MR400 Instructions for Use The following CO2 menu items are available: Size Grids Zero Cal Note Apnea and Apnea Time will be in the CO2 menu when bellows (BEL) is the selected RESP > Source; see page 10-7 for setting details. To change settings in the CO2 menu Step Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. Touch the menu item to select one of the following CO2 options: Size Grids Zero Cal The menu item appears. The current setting is highlighted. Select the desired setting from the menu options (except Grids, which is selectable on the CO2 menu). The setting is entered. To change other settings, repeat steps 2 and 3. Size Controls the size of the CO2 waveform. The following options are available: • 40 mmHg (Default) • 60 mmHg • 80 mmHg Expression MR400 Instructions for Use Monitoring CO2 (LoFlo Option) 7‐13 To adjust the size of the CO2 waveform Step Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. Select Size. The Size menu appears. The current setting is highlighted. Select the desired size: 40 mmHg 60 mmHg 80 mmHg The setting is changed. Grids Displays a scaled grid, which is graduated according to the Size selection for the CO2 waveform. Size Grid The following options are available: • Off does not display a grid. (Default) • On displays a grid. Note Grids will not be displayed during a CO2 Accuracy Check; see page 3-30. 7‐14 Monitoring CO2 (LoFlo Option) Expression MR400 Instructions for Use To control the display function for the CO2 grid Step Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. Locate Grids and select the desired setting: Off On The setting is entered. Zero Cal Initiates a zero calibration (an automatic function during normal use) of the CO2 system to allow for the different characteristics of each accessory type. Zero Cal is not required when switching sampling lines. Under certain conditions, Zero Cal will not be allowed: • If less than 20 seconds have passed since detection of the last breath; • If the CO2 temperature is unstable; or • If the sampling line is disconnected from the CO2 port. To perform a zero calibration See page 7‐2. Expression MR400 Instructions for Use Monitoring CO2 (LoFlo Option) 7‐15 7‐16 Monitoring CO2 (LoFlo Option) Expression MR400 Instructions for Use CHAPTER 8 Monitoring Invasive Blood Pressure When equipped with the invasive blood pressure option, the MR400 provides compatibility with standard invasive blood pressure transducers having a 5 µV/V/mmHg sensitivity, and offers two invasive blood pressure channels, P1 and P2. Indications and Contraindications Adult and Pediatric Patients Indications • Direct arterial pressure monitoring • Left atrial monitoring with an air‐eliminating filter between solution source and continuous flush device • Pulmonary artery monitoring (PA distal) • Venous pressure monitoring (RA proximal) • Cardiac catheterization Contraindications • Left atrial monitoring without an air‐eliminating filter between solution source and continuous flush device • Intracranial pressure monitoring • Compartmental pressure monitoring • Intrauterine pressure monitoring Neonatal Patients WARNING Do not use a pressure administration cuff. Indications • Umbilical artery catheterization of neonates • Invasive pressure monitoring with infusion pump Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐1 Contraindications • Left atrial monitoring without an air‐eliminating filter between the solution source and continuous flush device • Intracranial pressure monitoring • Compartmental pressure monitoring • Intrauterine pressure monitoring Patient Preparation for IBP Monitoring When positioning the patient, routine IBP measurements (including for the condition hypertension) require the patient to remain silent, still and relaxed, with legs uncrossed and arms supported. Note that during MRI procedures, patients are typically laying down with their legs uncrossed and arms supported as needed for the MRI scan. We also recommend waiting 5 minutes before taking readings. Transducer Component, Connection, and Feature Locations The illustration below details the pressure transducer (REF 989803179721) component, feature, and connection locations. If using a different kit, refer to the manufacturers instructions which accompany that kit. 8‐2 Monitoring Invasive Blood Pressure To patient Site line Zero reference stopcock Zero port Transducer Transducer cable Expression MR400 Instructions for Use 7 Press here to disconnect transducer from reusable cable Reusable cable connector Transducer cable connector 10 To fluid source 11 Squeeze continuous flush device MR 400 Preparation for IBP Monitoring Follow the procedure below to prepare the MR400 for IBP monitoring when using the Expression MR IBP DPT Kits (Adult / Pediatric, REF 989803194631; and, Infant/Neonatal, REF 989803194641). As there are preparation differences, always follow the appropriate procedure. To prepare the MR400 for IBP monitoring using transducer kits other than those referenced below, or for components added to the monitoring system, refer to applicable manufacturer’s instructions for set up and use. WARNINGS • Invasive blood pressure transducers are sensitive to vibrations that can occur during MRI scanning, which can lead to pressure reading inaccuracies. Always mount the invasive blood pressure transducer away from areas where vibration is likely to occur. • The fluid within the pressure transducer system is a conductive connection to the patient, and must not contact other conductive parts, including earth ground. • Do not allow fluids to enter the electrical connections of the transducer cables. Erratic readings may result. • Always reference the manufacturer’s instructions and follow the safe use instructions included with the IBP transducer kit when monitoring invasive blood pressure. • Never attach the pressure transducer(s) directly to the patient as excessive heating can occur resulting in burn injuries to the patient. • If air bubbles appear in the tubing system, flush the system with the infusion solution again. Air bubbles may lead to a wrong pressure reading. • Transducers do not protect against burns when used with high-frequency (HF) surgical equipment. • A transducer cable or other cable that becomes inadvertently looped during an MRI examination may act as conductive lines for RF induced currents, resulting in excessive heating and possible burns. When transducer cables or other cables form a conductive loop in contact with the patient's tissue, minor to severe burning can result. Do not allow the transducer cable or other cable to touch the patient or to become looped. Please refer to the additional information in Appendix E to prevent excessive heating associated with MRI procedures. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐3 WARNING Disposable attachments are designed for single patient use and must be disposed after use. They must not be cleaned and reused. Follow your hospital’s guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. CAUTION Use only approved pressure transducers and cables, as listed in Accessories in chapter 1, and follow the Instructions for Use that are supplied with the pressure transducer to set up and use the transducer monitoring kit. Note The procedure below details the connection of a single transducer. To monitor two IBP channels, repeat the procedure to connect an additional transducer to the unused IBP port on the MR400. Adult and Pediatric Patients: Expression MR IBP DPT Kit, A/P (REF 989803194631) I. Connecting the Reusable Cable to the MR400 Connect the reusable cable, REF 989803194601 (or equivalent), to the P1 or the P2 port on the patient connection panel. P1 port P2 port Reusable cable (REF 989803194601, or equivalent) 8‐4 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use II. Kit Set Up Set up the disposable transducer monitoring kit using aseptic technique. Step Action Open package containing the sterile disposable transducer monitoring kit. Remove transducer monitoring kit assembly from the package. Check all fittings to ensure tight connection. Connect the reusable cable, REF 989803194601 (or equivalent), to the transducer cable. Reusable cable (REF 989803194601, or equivalent) Transducer cable Transducer Prepare a collapsible I.V. solution bag by extracting all air from the bag. If heparinizing, add heparin prior to air removal. CAUTION If an air-free solution source is not used (i.e., air is not extracted from the fluid source), air may be forced into the monitoring line when solution is exhausted. Close the clamp on the administration set and remove the protective cap from the administration set spike. Insert the spike carefully into the I.V. solution bag. CAUTION To prevent inadvertent puncture of the I.V. solution bag, insert the spike carefully using a twisting motion. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐5 Step Action Insert the I.V. solution bag into the pressure administration cuff. Hang the pressure administration cuff from an MR I.V. pole. With the administration set clamp closed, gently squeeze the drip chamber and fill drip chamber approximately 1/2 full. Open clamp on administration set. III. Purging Air from the Monitoring Line A. Attach the transducer to an MR IV pole mount. B. Turn zero reference stopcock “off” to patient. Remove white vented cap from the side port of the zero reference stopcock. C. Activate fast flush mechanism of the continuous flush device and fill transducer slowly (gravity prime only) until air‐free. Flush fluid through transducer and side port of stopcock. D. Turn handle of zero reference stopcock “off” to its side port. Place a yellow non‐vented cap onto the side port of the stopcock. E. Repeat priming steps B–D for any additional stopcocks. F. Remove white cover at patient connector and flush the rest of the patient line. Place a yellow non‐vented cover onto the patient connector. Note Take care to ensure no air is trapped in any components of the fluid pathway. The monitoring system must be totally air-free for maximum performance, i.e., optimal dynamic response. G. Pressurize the I.V. solution source to 300 mmHg. Close clamp on pressure cuff. CAUTIONS • Make certain the drip chamber does not completely fill during pressurization. Air should remain in the drip chamber so that the continuous flush rate can be verified following a fast flush. • Pulling a vacuum to purge bubbles from the lines is not recommended. This practice may entrain air or release air from solution. If the line is primed in a forward manner under pressure, care must be taken to assure the maximum pressure specifications for the transducer are not exceeded. 8‐6 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use IV. Zeroing, Leveling and Calibration A. After the system has been primed and mounted, zero the transducer using one of the following methods: Step Action Turn the zero reference stopcock “off” to the patient and remove yellow non‐vented cap from the side port which opens the zero reference stopcock to air. Note The air-fluid interface of the zero reference stopcock should be at or near the right atrial (mid-axillary) level. Zero the transducer. Press the Zero All key. (Otherwise, to zero a single channel, use Zero Set in the respective P1 or P2 menu; see page 8‐24). Zeroing All Pressure Channels (or Zeroing Pressure Channel for a single channel if Zero Set was used) will be displayed and zeroing will begin; where, upon completion, Done will be displayed to indicate success. Note If the transducer will not zero and an error condition occurs, verify that the transducer is being used as described in the manufacturer’s instructions. Press Retry to attempt zeroing again. If the transducer still does not zero, try another transducer and/or cable; and, if condition persists, contact technical support or authorized service personnel. Turn the zero reference stopcock “off” to the side port and replace yellow non‐vented cap. —Or— Step Expression MR400 Instructions for Use Action Attach desired catheter to distal end of monitoring kit and prime, purging all air bubbles from catheter. Open stopcock(s) to the catheter. (The catheter tip is now the system air‐fluid interface.) Monitoring Invasive Blood Pressure 8‐7 Step Action Place transducer in the position (horizontal plane) it will maintain during pressure measurement. Place the catheter tip at the right atrial (mid‐axillary) level. Zero the transducer. Zero the transducer. Press the Zero All key. (Alternatively, use Zero Set in the respective P1 or P2 menu to zero a specific channel connected to the transducer; see page 8‐24). Zeroing All Pressure Channels (or Zeroing Pressure Channel for a single channel if Zero Set was used) will be displayed and zeroing will begin; where, upon completion, Done will be displayed to indicate success. Note If the transducer will not zero and an error condition occurs, verify that the transducer is being used as described in the manufacturer’s instructions. Press Retry to attempt zeroing again. If the transducer still does not zero, try another transducer and/or cable; and, if condition persists, contact technical support or authorized service personnel. B. Repeat this zeroing, leveling, and calibration procedure for each additional monitoring line as applicable. C. Transducers are pre‐calibrated to industry standards. V. Connecting the Monitoring Kit to the Patient WARNING The IBP transducer must not be mounted to the patient, or patient burn may result. A. Remove yellow non‐vented cover at patient connector. A continuous flush of approximately 3 ml per hour should be observed in the drip chamber. Drop rate should be approximately 1 drop per minute. For each additional monitoring line, the continuous flush will increase by 3 ml/hr (i.e., 6 ml/hr for two lines). B. For a systemic arterial blood pressure line, activate the fast flush mechanism of the continuous flush device, while allowing arterial cannula to backflow during attachment. For pulmonary artery catheters, the monitoring kit should be attached to the catheter and the 8‐8 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use catheter filled with I.V. solution prior to insertion. Follow catheter manufacturer’s insertion instructions. VI. Fast Flushing A. Activate the fast flush mechanism of the continuous flush device and check drip chamber to confirm fast flush. B. FOLLOWING EACH FAST FLUSH, DRIP CHAMBER DROP RATE MUST BE OBSERVED TO VERIFY COMPLETE CLOSURE. VII. Checking for Leaks After approximately 1 minute has elapsed, the flow rate should be observed at the drip chamber to ensure that the continuous flush device is operating properly. A visual inspection for leaks should also be made since a small leak can misrepresent the actual continuous flow through the catheter. A protocol should be established according to the hospital standard of care for routinely checking the system for proper fluid source pressure, flow rate and leaks. VIII. In the MR Room WARNINGS • The IBP transducer must not be allowed past the 5,000 gauss line, or transducer failure, inaccurate readings, noisy MRI images or patient burn may result. • Never place the pressure transducer’s stopcocks or port covers within 8 cm (3.2 inches) of the field of view of the MR bore as inaccurate readings or noisy MRI images can result. • An offset occurs when the pressure transducer is repositioned in the magnetic field. The transducer must be zeroed prior to the MRI examination after the transducer is in its final setup position. Moving the transducer after zeroing may cause a measurement offset to occur. In the MR room, ensure that the transducer is level with the heart that the transducer interface cabling is not looped or touching the patient (refer the Warnings on pages 8‐3 and 8‐4), and then re‐zero the transducer; see page 8‐16. WARNING Non-physiological pulsatile P1 (or P2) waveform (for example, those found during intraaortic balloon pump use) can lead to inaccurate blood pressure readings. If questionable values are observed, recheck the patient’s pressures by alternate means before administering medication or therapy. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐9 Note When monitoring invasive blood pressure, routinely inspect the catheter and/or pressure line for leaks after zeroing, and always follow the pressure transducer/catheter manufacturer’s use recommendations. Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641) I. Connecting the Reusable Cable to the MR400 Connect the reusable cable, REF 989803194601 (or equivalent), to the P1 or the P2 port on the patient connection panel. P1 port P2 port Reusable cable (REF 989803194601, or equivalent) II. Kit Set Up A. Set up the disposable transducer monitoring kit using aseptic technique Step 8‐10 Monitoring Invasive Blood Pressure Action Open package containing the sterile disposable transducer monitor‐ ing kit. Remove transducer monitoring kit assembly from package. Attach additional monitoring components as desired. Check all fittings to ensure tight connections. Expression MR400 Instructions for Use Step Action Connect the reusable cable, REF 989803194601 (or equivalent), to the transducer cable. Reusable cable (REF 989803194601, or equivalent) Transducer cable Transducer B. Preparing Solution Step Action Assemble pump administration set appropriate for the infusion pump that is to be used. If using heparin, add prior to air removal. CAUTION If an air-free solution source is not used (i.e., air is not extracted from the fluid source), air may be forced into the monitoring line when solution is exhausted. Attach tubing to solution container and prime the tubing following pump manufacturer’s instructions. Note If an air-free solution source is not used (i.e., air is not extracted from the fluid source), air may be forced into the monitoring line when solution is exhausted. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐11 C. Connecting Kit to the Infusion Pump Step Action Remove vented cap from the female port of flush device and con‐ nect flush device fluid line to distal connector of infusion pump administration set. CAUTION In this application, the flush device is not intended to control flow rate. Flow rate must be controlled by an infusion pump. Do not use with pressure administration cuff. III. Purging Air from the Monitoring Line A. Remove the vented cap from the stopcocks and the vented cover from the patient connector (distal stopcock). B. Adjust the pump delivery regulator to a fluid flow rate sufficient to flush solution through the system. C. Carefully fill fluid lines of the monitoring kit with I.V. solution until all air has been removed from the system. Activate flush device to facilitate filling and to remove air from flush device. Turn stopcock handles as applicable to prime through side ports of stopcocks. Non‐vented caps and covers are provided in the spare parts bag to replace vented caps and covers as required. CAUTION Pulling a vacuum to purge bubbles from the lines is not recommended. This practice may entrain air or release air from solution. If the line is primed in a forward manner under pressure, care must be taken to assure the maximum pressure specifications for the transducer are not exceeded. Note Take care to ensure no air is trapped in any components of the fluid pathway. The monitoring system must be totally air-free for maximum performance, i.e., optimal dynamic response. IV. Zeroing, Leveling and Calibration A. After the system has been primed and mounted, zero the transducer using one of the following methods: 8‐12 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use Step Action Turn the zero reference stopcock “off” to the patient and remove non‐vented cap from the side port which opens the zero reference stopcock to air. Note The air-fluid interface of the zero reference stopcock should be at or near the right atrial (mid-axillary) level. Zero the transducer. Press the Zero All key. (Otherwise, to zero a single channel, use Zero Set in the respective P1 or P2 menu; see page 8‐24). Zeroing All Pressure Channels (or Zeroing Pressure Channel for a single channel if Zero Set was used) will be displayed and zeroing will begin; where, upon completion, Done will be displayed to indicate success. Note If the transducer will not zero and an error condition occurs, verify that the transducer is being used as described in the manufacturer’s instructions. Press Retry to attempt zeroing again. If the transducer still does not zero, try another transducer and/or cable; and, if condition persists, contact technical support or authorized service personnel. Turn the zero reference stopcock “off” to the side port and replace non‐vented cap. —Or— Step Expression MR400 Instructions for Use Action Attach desired catheter to distal end of monitoring kit and prime, purging all air bubbles from catheter. Open stopcock(s) to the catheter. (The catheter tip is now the sys‐ tem air‐fluid interface.) Place transducer in the position (horizontal plane) it will maintain during pressure measurement. Place the catheter tip at the right atrial (mid‐axillary) level. Monitoring Invasive Blood Pressure 8‐13 Step Action Zero the transducer. Press the Zero All key. (Alternatively, use Zero Set in the respective P1 or P2 menu to zero a specific channel connected to the transducer; see page 8‐24). Zeroing All Pressure Channels (or Zeroing Pressure Channel for a single channel if Zero Set was used) will be displayed and zeroing will begin; where, upon completion, Done will be displayed to indicate success. Note If the transducer will not zero and an error condition occurs, verify that the transducer is being used as described in the manufacturer’s instructions. Press Retry to attempt zeroing again. If the transducer still does not zero, try another transducer and/or cable; and, if condition persists, contact technical support or authorized service personnel. B. Transducers are pre‐calibrated to industry standards. V. Connecting the Monitoring Kit to the Patient WARNING The IBP transducer must not be mounted to the patient, or patient burn may result. A. Remove non‐vented cover at patient connector. B. Set the infusion pump to deliver the desired flow rate. Continuous low flow flush should be observed at the patient connector and drip chamber (if provided) at this time. CAUTION Kits with a 30 ml per hour flush device are not intended to control flow rate. Flow rate must be controlled by an infusion pump. Do not use with pressure administration cuff. C. Activate pump delivery mechanism to pump solution through the flush device while allowing arterial cannula to back flow during attachment. 8‐14 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use CAUTIONS • Be certain not to introduce air into the system during connection procedure. • If this product is used with fat emulsions, they must be introduced through the lipid compatible stopcock that is distal to the flush transducer assembly to avoid cracking of the transducer line. VI. Checking for Leaks After approximately 1 minute has elapsed, the flow rate should be observed at the drip chamber to ensure that the continuous flush device is operating properly. A visual inspection for leaks should also be made since a small leak can misrepresent the actual continuous flow through the catheter. A protocol should be established according to the hospital standard of care for routinely checking the system for proper fluid source pressure, flow rate and leaks. VII. In the MR Room WARNINGS • The IBP transducer must not be allowed past the 5,000 gauss line, or transducer failure, inaccurate readings, noisy MRI images or patient burn may result. • Never place the pressure transducer’s stopcocks or port covers within 8 cm (3.2 inches) of the field of view of the MR bore as inaccurate readings or noisy MRI images can result. • An offset occurs when the pressure transducer is repositioned in the magnetic field. The transducer must be zeroed prior to the MRI examination after the transducer is in its final setup position. Moving the transducer after zeroing may cause a measurement offset to occur. In the MR room, ensure that the transducer is level with the heart that the transducer interface cabling is not looped or touching the patient (refer to the Warnings on pages 8‐3 and 8‐4), and then re‐zero the transducer; see page 8‐16. WARNING Non-physiological pulsatile P1 (or P2) waveform (for example, those found during intraaortic balloon pump use) can lead to inaccurate blood pressure readings. If questionable values are observed, recheck the patient’s pressures by alternate means before administering medication or therapy. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐15 Note When monitoring invasive blood pressure, routinely inspect the catheter and/or pressure line for leaks after zeroing, and always follow the pressure transducer/catheter manufacturer’s use recommendations. Zeroing the Pressure Transducer WARNING The transducer must be zeroed prior to the MRI examination after the transducer is in its final setup position. Moving the transducer after zeroing may cause a measurement offset to occur. Otherwise, inaccurate patient pressure readings may result. To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital policy (at least once per day). You must perform a zero: • when you use a new transducer or tubing, • every time you reconnect the transducer cable to the monitor, or • if you think the monitor’s pressure readings are not correct. To zero a pressure transducer Refer to the appropriate procedure according to the patient type and application: • Adult / Pediatric—see page 8‐7. • Neonate—see page 8‐12. P1 and P2 Waveforms and VS Boxes Invasive blood pressure measurements (P1 and P2) are displayed as waveforms (trace E and trace F, respectively) in the VS trace area of the screen and as numeric information in the P1 and P2 VS boxes. Other data, including P1‐ and P2‐related alarm information, are also provided in these areas of the screen, as detailed below. 8‐16 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use Note Except for the VS box annotations and waveform locations, the definitions described below are applicable to both P1 and P2 channels. Systolic/Diastolic Format 6 7 12 Item Name Definition Is the detected P1 (or P2) waveform, Trace E (or Trace F) P1 VS waveform, or P2 VS waveform 11 10 Note To change the waveform speed, see Sweep Speed on page 3-25. Alarm flag area Displays P1 (or P2) alarm flags when detected; see page 4-31. P1 (or P2) VS box label Indicates the P1 (or P2) vital sign parameter, and accesses the P1 menu (or P2 menu) Unit of measure Indicates that the pressure measurement numeric values are given in mmHg (millimeters of mercury) or kPa (kilopascals); see Pressure Units on page 3-32. Systolic numeric Is the patient’s detected systolic invasive blood pressure measurement Diastolic numeric Is the patient’s detected invasive diastolic blood pressure measurement Systolic upper alarm limit Is the upper limit setting for the P1 (or P2) systolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) Diastolic upper alarm limit Is the upper limit setting for the P1 (or P2) diastolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐17 Item Name Definition Diastolic lower alarm limit Is the lower limit setting for the P1 (or P2) diastolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) 10 Systolic lower alarm limit Is the lower limit setting for the P1 (or P2) systolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) 11 Mean numeric Indicates the patient’s detected mean invasive blood pressure measurement 12 or Indicates the Set Label name, if assigned, for P1 (or P2) Mean Format 10 Item Name Definition Is the detected P1 (or P2) waveform, Trace E (or Trace F) P1 VS waveform, or P2 VS waveform Note To change the waveform speed, see Sweep Speed on page 3-25. Alarm flag area Displays P1 (or P2) alarm flags when detected; see page 4-31. P1 (or P2) VS box label Indicates the P1 (or P2) vital sign parameter, and accesses the P1 menu (or P2 menu) Unit of measure Indicates that the pressure measurement numeric values are given in mmHg (millimeters of mercury) or kPa (kilopascals); see Pressure Units on page 3-32. Mean numeric Is the patient’s detected mean invasive blood pressure measurement Mean upper alarm limit Is the upper limit setting for the P1 (or P2) mean alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) 8‐18 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use Item Name Definition Mean lower alarm limit Is the lower limit setting for the P1 (or P2) mean alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) Diastolic numeric Is the patient’s detected invasive diastolic blood pressure measurement Systolic numeric Indicates the patient’s detected systolic invasive blood pressure measurement 10 or Indicates the Set Label name, if assigned, for P1 (or P2) Changing the P1 (or P2) Format To control the format of the P1 (or P2) data Step Action Select the P1 (or P2) VS box. The P1 menu (or the P2 menu) appears. Current settings are displayed. Select Format. The Format menu appears. The current setting is highlighted. Select the desired format: SysDia Mean The format is changed. Note When using P1 (or P2) labels CVP or ICP, the displayed format cannot be changed; see page 8-28 for details. Changing the P1 (or P2) Waveform Amplitude The vertical scale of the displayed P1 (or P2) waveform can be changed to best suit the viewing requirements. Always select the appropriate waveform scale for the waveform being observed. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐19 To change the P1 (or P2) waveform amplitude Step Action Select the P1 (or P2) VS box. The P1 (or P2) menu appears. Current settings are displayed. Select Size. The Size menu appears. The current setting is highlighted. Select the desired size: 40 mmHg 75 mmHg 100 mmHg 150 mmHg (Default) 200 mmHg 250 mmHg The setting is changed. Changing the P1 (or P2) Alarm Limits The P1 Alarm Limits menu can be accessed by touching the alarm limit settings in the P1 vital sign box, and the P2 Alarm Limits menu can be accessed by touching the alarm limit settings in the P2 vital sign box. Except for menu labeling differences, the elements described below are applicable to both the P1 and P2 parameters. 10 11 12 6 5 4 3 2 Alarm limit settings, P1 VS box High button Low button P1 Diastolic Alarm Limits menu label P1 Mean Alarm Limits menu label Enter button 8‐20 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use 7 Current adjustment P1 Systolic Alarm Limits menu label (active adjustment shown) Alarm limit, minimum 10 Lower P1 (Sys) alarm limit setting 11 Upper P1 (Sys) alarm limit setting 12 Alarm limit, maximum To change the invasive blood pressure alarm limit settings Step Action Select the alarm limit settings in the P1 (or P2) VS box. The P1 Alarm Limits (or the P2 Alarm Limits) menu appears. Current settings are displayed. Select the desired pressure setting: P1 (Sys) P1 (Dia) P1 (Mean) The setting is selected. Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the change. Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining settings, repeat steps 2, 3, 4 and 5. The current adjustment will reflect the change. Note See chapter 4 for detailed alarm limit setting instructions and options. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐21 Changing the Unit of Measure Note When using an IP5 and Pressure Units is changed, the displayed formatting of the value and placement of the decimal point is changed immediately. However, it can take up to 2 seconds for the measurement numeric values to reflect the new unit of measure. Do not print or perform data captures during this period. To change the unit of measure Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) menu appears. Current settings are displayed. On the Service(Bio‐Med) menu, select System Config. The System Config menu appears. Current settings are displayed. On the System Config menu, select Pressure Units. The Pressure Units menu appears. The current setting is highlighted. Select the desired setting: mmHg kPa The setting is entered. P1 (and P2) Menu The P1 and P2 menus allow you to control invasive blood pressure traces, functions and settings. Each menu contains identical options for the control of the respective invasive blood pressure channel, P1 or P2. Note The operation and menus for P1 and P2 are identical. 8‐22 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use To open the P1 menu (or P2 menu) Select the P1 VS box (or the P2 VS box). P1 menu P1 VS box The following P1 (and P2) menu items are available:. Zero Set Set Label Size HR Source Grids Grids Size Format To change settings in the P1 (or P2) menu Step Action Select the P1 (or P2) VS box. The P1 (or P2) menu appears. Current settings are displayed. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐23 Step Action Touch the menu item to select one of the following P1 (or P2) options: Zero Set Set Label Size HR Source Grids Grids Size Format The menu item appears. The current setting is highlighted. Select the desired setting from the menu options (except Grids, which is selectable on the P1 [or P2] menu): The setting is entered. To change other settings, repeat steps 2 and 3. Zero Set Zeros the pressure transducer for P1 (or P2). The pressure transducer must be zeroed before use and at regular intervals during use. (Zero Pressure Channel will be displayed during the process and Done will be displayed upon completion.) To zero the pressure transducer See Zeroing the Pressure Transducer on page 8‐16. Set Label Assigns a label to the pressure channel for identification of the transducer site. The label will appear in the VS box and it will also determine the color used for the VS box. The following names and colors are available: • None displayed in white. (Default) • ABP (arterial blood pressure) displayed in pink. Note In the event ABP is chosen as the heart rate source while there are multiple pressures labeled as ABP, the system will choose P1. • PAP (pulmonary artery pressure) displayed in yellow. 8‐24 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use • CVP (central venous pressure) displayed in blue. • LAP (left atrial pressure) displayed in purple. • ICP (intracranial pressure) displayed in light blue. To assign a label to an P1 (or P2) channel Step Action Select the P1 (or P2) VS box. The P1 menu (or the P2 menu) appears. Current settings are displayed. Select Set Label. The Set Label menu appears. The current setting is highlighted. Select the desired label: None ABP PAP CVP LAP ICP The label is changed. The annotation in the VS box and its color is updated. Size Changes the P1 (or P2) waveform amplitude, allowing low level signals to be scaled up or high level signals to be scaled down for better viewing. The following options are available: • 40 mmHg • 75 mmHg • 100 mmHg • 150 mmHg (Default) • 200 mmHg • 250 mmHg To change the amplitude of the P1 (or P2) waveform See Changing the P1 (or P2) Waveform Amplitude on page 8‐19. Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐25 HR Source Selects the source that produces the heart rate, as displayed in the ECG and SPO2 VS boxes (identical to and interactive with same option in the ECG and SPO2 menus). The following options are available: • Auto sets the source automatically according to the highest priority active input that is first to report valid patient data. The priority ranking (highest to lowest) is ECG, P1, P2, SPO2 (provided that the P1 and P2 channels have been labeled ABP; see Set Label on page 8‐24 for details). The source will become unavailable when it has produced no valid data for a period of ten (10) or more seconds. The system examines the highest priority active input. If not found, the second‐highest priority input is chosen, et cetera. If none are present, then None is displayed as the heart rate measurement numeric. • ECG sets ECG as the source. (Default) • ABP sets ABP as the source (if no pressure channel is labeled ABP, a warning box will allow automatic renaming and selection before proceeding; also see Set Label on page 8‐24). • SPO2 sets SPO2 as the source. To set the heart rate source Step Action Select the P1 (or P2) VS box. The P1 menu (or the P2 menu) appears. Current settings are displayed. Select HR Source. The HR Source menu appears. The current setting is highlighted. Select the desired setting for the heart rate source: Auto ECG ABP SPO2 The source is changed. Grids Controls the pressure grid display for IBP waveforms. 8‐26 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use Grids Size Grid The following options are available: • Off no grid is displayed. (Default) • On displays a scaled grid (also see Grids Size, below). To control the display function for the pressure grid Step Action Select the P1 (or P2) VS box. The P1 menu (or the P2 menu) appears. Current settings are displayed. Locate Grids and select the desired setting: Off On The setting is entered. Grids Size Sets the scale size when Grids is on (see Grids, above). The following options are available: • 40 mmHg • 75 mmHg • 100 mmHg • 150 mmHg (Default) • 200 mmHg • 250 mmHg Expression MR400 Instructions for Use Monitoring Invasive Blood Pressure 8‐27 To adjust the grid size for the P1 (or P2) waveform Step Action Select the P1 (or P2) VS box. The P1 menu (or the P2 menu) appears. Current settings are displayed. Select Grids Size. The Grids Size menu appears. The current setting is highlighted. Select the desired size: 40 mmHg 75 mmHg 100 mmHg 150 mmHg 200 mmHg 250 mmHg The setting is changed. Format Sets the displayed format of the P1 (or P2) numeric data, except when using certain pressure channel labels. The following options are available: • SysDia displays the systolic and diastolic numerics in a large font (separated by a slash) and displays the mean numeric in a smaller font (bracketed with parenthesis). (Default) • Mean displays the mean numeric in a large font, and the systolic and diastolic numerics in a smaller font and separated by a slash. Only mean alarms will be present in this format. Also, labels (i.e., CVP and ICP) that designate single pressures will automatically assume the mean format; see Set Label on page 8‐24. To control the format of the P1 (or P2) numeric data See Changing the P1 (or P2) Format on page 8‐19. 8‐28 Monitoring Invasive Blood Pressure Expression MR400 Instructions for Use CHAPTER 9 Monitoring Agents and Gases (AGENT Option) When equipped with the AGENT option, the patient’s level of anesthetic agent gases, oxygen (O2), carbon dioxide (CO2), and nitrous oxide (N2O) concentrations can be monitored. An anesthetic gas sensor (AGS) system uses infrared spectroscopy combined with digital signal processing to quickly and accurately identify gas concentrations. WARNING Whenever a patient is under anesthesia or connected to a ventilator, constant attention by qualified medical personnel is required. MR400 Preparation for AGENT Monitoring When preparing the MR400 for AGENT monitoring, ensure that the waste gas port (see page 1‐ 19) has been connected to your facility’s gas scavenging system for disposal of sampled and calibration gases. Notes • These instructions are for setting up a typical monitoring system. Exact components and setup procedure used may vary, depending upon the application. For components added to the monitoring system, refer to applicable manufacturer’s instructions for set up and use. • Never route the waste gas tubing in a location that will allow it to be an obstruction or stepped on. Operation and Use When monitoring anesthetic agent gases, the typical operations and possible conditions that can arise may result in potential messages requiring your attention. See page 4‐26 for a message listing and suggested actions. Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐1 WARNINGS • Organic vapors (for example, from cleaning agents) in the sampling line or room air may alter anesthetic agent readings. • Alcohol in the patient’s breath can modify the anesthetic agent readings. Warm-Up Period In order to achieve accurate identifications and measurements, the AGS system requires a warm‐ up period to thermally stabilize. This warm‐up period begins when the AGENT or the CO2 parameter is activated. Upon activation, the AGS system will become fully operational according to the following sequence: 1. During the warm‐up period, CO2 Warming Up will be displayed. 2. Within 45 seconds of activation, the AGS system will be able to identify the gases and provide gas concentration information with ISO‐level accuracy. Wait during this period, the measurement numeric values in the AGENT, GAS, and CO2 VS boxes will display three dashes (‐ ‐‐ ); see No Data Indication on page 2‐20 for details. 3. Within 10 minutes of activation, the AGS system will be able to operate at full accuracy. Zero Reference Adjustment WARNING During Zero calibration the system pulls ambient air through the zero intake port on the cart The calibration system assumes that the ambient air will contain normal trace amounts of CO2. If the system is placed in an unventilated area that allows CO2 (from the waste gas port on the rear panel, if not connected to a gas scavenging system) to accumulate, the result could be inaccurate CO2 zeroing and resulting inaccurate patient readings. Always place the cart in a well ventilated area. The AGS system will occasionally perform a zero reference adjustment, briefly interrupting gas monitoring to take in room air through a reference gas intake port to ensure the accuracy of the displayed gas concentrations. Readjusting CO2 Zero will be displayed during a zero reference adjustment; allow the process to complete. A zero reference adjustment typically takes 10–12 seconds, and will occur automatically as needed, but mostly during the warm‐up period. When the AGS system has become fully operational, these adjustments will occur approximately once every 4 hours or whenever the AGS system temperature changes by at least ±1°C from the last stored stable temperature. 9‐2 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use Note Whenever the Agent sensor changes from a steady state condition, the system will perform an zero reference adjustment to restabilize the sensor readings. During this time it is possible for a false identification and concentration value to occur. Change from a steady state condition may occur when: – Applying a sampling line for the first time. – Switching from one agent to another. – Going from high agent concentrations to low or off. Note During the first hour after the system has been turned on and flowing oxygen greater than 50 percent, the CO2 waveform periodically baselines to complete reference measurement; however, the measurement numeric values remain. Once the system reaches ambient temperature this condition will cease to occur. To perform a manual zero reference adjustment Step Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. Select Zero Cal. Allow the process to complete, typically 10–12 seconds. Breath Rate Distortion The effect of rise time distortion to the gas curve becomes apparent when the breathing rate increases so that the time for a full inspiratory or expiratory event gets shorter. In those situations, due to the effect of the rise time, the gas curve does not reach the true end‐tidal (or first inspired value) and the end‐tidal gas value may then be underestimated. Correspondingly, the first inspired value may be overestimated. Below is an exaggerated illustration of the effect. Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐3 - - at gas sampling site — as presented by gas analyzer Et error Percent Fi error Time The breath rate limit for accurately resolved end‐tidal gas values (at an I:E ratio of 1:1) may be found in Appendix A. The effect of other I:E ratios may be calculated by determining the length of the shortest inspiratory/expiratory event that can be resolved accurately: tresolved = 60 / (2 x BRlimit(1:1) BRlimit(I:E) = 60 / ((I + E) x tresolved) The difference in these results when compared to the rise time's specification is that rise time's only tests 10‐90% performance. This specification is for (0 + accuracy) to (100 ‐ accuracy) % and is thus much tougher. The ability to properly resolve end‐tidal values can be measured by using the set‐up described in ISO 80601‐2‐ 55:2011 figure 201.101. In short, the method consists of sampling gas from two different sources connected to an electrically controlled pneumatic valve to permit rapid switching between the two sources. During the test, the valve is set to switch gas source at a number of frequencies (simulating the range of specified breath rates) and for each frequency the end‐tidal value presented by the gas analyzer is noted. From a diagram of end‐tidal value over frequency, the frequency at which the gas analyzer is no longer able to resolve end‐ tidal values according to specification is identified. This ability to properly resolve end‐tidal values is listed in the specification. CO2 Low Flow and Occlusion Conditions CO2 Low Flow will be displayed and an alarm will sound in the event of a low flow condition (whenever the gas flow falls to an amount that is 10 percent less than the sample flow rate for the selected patient type), as shown in the table below. Patient Type Sample Flow Rate Flow Rate when Low Flow is Declared Adult 200 ml/min ≤ 180 ml/min Pediatric 200 ml/min ≤ 180 ml/min Neonate 150 ml/min ≤ 135 ml/min Occlusion will be displayed and an alarm will sound in the event of an occlusion condition (whenever the gas flow rate has fallen below 40 ml/min for at least 1 second. The typical cause of 9‐4 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use the low flow or the occlusion condition is due to a pinched sampling line, or a blocked sampling line due to excessive moisture from patient expiration. Selecting AGENT Accessories Various accessories are available for use with the AGENT option. For example, when monitoring patients on a breathing circuit, a sample of the respiratory gas is drawn from the patient’s breathing circuit through an airway adapter and sampling line, or when patients are not on a breathing circuit, the sample is drawn through a nasal cannula. When selecting AGENT accessories (see page 1‐34 for a listing), consider the following: • The type of patient (adult, pediatric, or neonatal) • The condition of the patient • Whether the patient is on a breathing circuit • Whether the patient is receiving supplemental oxygen • All accessories are single use. AGENT Tubing Preparation Various pneumatic circuit configurations for use with the AGENT option are illustrated below: • Monitoring using the airway adapter Expression MR400 Instructions for Use Water trap Sample port (with Luer lock connector) Sampling line Luer lock connector Airway adapter connected to the patient airway Monitoring Agents and Gases (AGENT Option) 9‐5 • Monitoring using the nasal cannula • Water trap Sample port (with Luer lock connector) Sampling line Luer lock connector Nasal cannula connected to a patient airway Monitoring using a divided nasal cannula (when delivering O2 to the patient) Water trap Sample port (with Luer lock connector) Sampling line Luer lock connector Large tubing connector to patient O2 source Divided nasal cannula connected to a patient airway 9‐6 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use To prepare the AGENT tubing Step Action Ensure that the water trap has been installed in the water trap receptacle (see page 9‐13 for installation instructions). Insert the Luer lock connector on the sampling line (REF 94018) into the sample port on the water trap and then tighten the connector (no more than one half‐turn should be required). Sample port Sampling line According the type of pneumatic circuit required to perform AGENT monitoring, connect the pneumatic circuit items (see the diagrams above). Where equipped with a Luer lock, only a half‐turn of the Luer lock connector should be required where equipped; otherwise, ensure that any tubing connector has been pressed firmly onto the associated adapter. Verify that each connection is tight by holding the nasal prongs (or the patient airway adapter) close to your ear and listening for a hissing sound. Increase the flow temporarily if necessary and then reduce to the prescribed flow rate once the flow is verified. Expression MR400 Instructions for Use On a daily basis, perform a system test; see page 9‐8 for details. Apply the sampling line to the patient (see page 9‐10). Monitoring Agents and Gases (AGENT Option) 9‐7 WARNINGS • Remove the sampling line from the patient airway whenever nebulized medications are being delivered. • Continuous exposure to waste anesthetic gases (including halogenated agents and nitrous oxide) is not recommended. Always connect a line between the system’s waste gas port and your facility’s gas scavenging/evacuation system. Avoid venting any waste anesthetic gas directly into the room air as exposure to these gases above the recommended OHSA limits could result. • Do not block the waste gas port on the system. Ensure that the exhaust gas is not removed from the system under too strong a vacuum. (To prevent this condition, there must always be an opening to the room air.) Too high a vacuum level will change the operating pressure of the system and cause inaccurate readings or internal damage. • Use only approved sampling lines and AGENT accessories, as other sampling lines and accessories will cause inaccurate readings and malfunctions. • Replace the sampling line, replace the airway adapter, and inspect the water trap between each patient use. CAUTIONS • Do NOT over-tighten the sampling line connection to the water trap; only a half-turn should be needed. Over-tightening this connection may damage the water trap and cause failure of the trap assembly. • Regularly inspect the line to facility’s gas scavenging system for deterioration, and replace the line if necessary. Pre-Use System Checks Prior to using the system for AGENT monitoring, it is recommended that the following initial checks be performed at least once. Step Action After the pneumatic tubing has been prepared as directed above (page 9‐5), turn on the system and activate AGENT in the Monitor Setup > Parameters menu; see page 3‐18. If Agent HW Fail ‐ O2 Sensor is displayed after activation of the parameter, replace the O2 sensor as described on page 14‐13. 9‐8 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use Step Action Allow the AGS system to run and sample room air for at least 1 minute. The FiO2 reading displayed in the GAS VS box should be approximately 21 percent. If the reading remains outside this range for more than 1 minute after first checking the reading, replace the oxygen sensor as described in chapter 14. After allowing the AGS system to run for at least 1 minute, pinch or seal the input line (to the water trap) for 5 seconds and verify that Occlusion is displayed. If this message does not appear, check all tubing connections for leakage and retest. WARNINGS • Always test sampling line adapter for a tight connection and proper operation before attaching to a patient. Over-tightening the sampling line connection may damage the water trap. Tighten the sampling line connector no more than one half-turn. Overtightening this connector can cause failure of the water trap assembly and inaccurate patient gas measurements. • Inspect water trap and AGENT accessories before use. If the sampling line, connector or sample port show signs of damage, replace the part immediately or discontinue use and contact technical support. Never use damaged equipment. • Frequently inspect the patient sampling line and keep it clear of any moving mechanisms (for example, table wheels) which could cut, pinch, or dislodge the patient tubing. Avoid kinking of the patient sampling line as leaks, reduced or stopped flow, or internal venting of sampled gas into damaged tubing will cause inaccurate measurements. • Do not position the sampling line in any manner that may cause entanglement or strangulation. • Replace the sampling line if excessive secretions are observed, as inaccurate measurements could result if the flow is reduced or stopped. • Leakages in the breathing system or sampling system may cause the displayed AGENT, CO2, O2, N2O values to be too low. Always connect all components securely and check for leaks according to standard clinical procedures. Displacement of the nasal cannula or patient airway adapter can cause lower than actual readings. • If AGENT, CO2, O2, N2O values for patients who are not on a breathing circuit appear extremely low, check whether the patient is breathing through the mouth or whether one nostril is blocked. Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐9 CAUTION Routinely inspect the hose assemblies for proper attachment and orientation. Replace hose assemblies with cracks, holes, tears, or cuts that could cause leaks in the system. If hose assemblies with damage that could result in leaks are used, prolonged and/or inaccurate patient readings could result. Note Always inspect the patient sampling line after attachment to the MR400. If questionable anesthetic agent gas measurements are observed, recheck the patient connections, the anesthesia gas machine, and/or the vaporizer before readjusting anesthesia delivery. Applying the Sampling Line to the Patient Select the AGENT patient accessory that is appropriate for the patient size and application. Patient nasal cannulas and sampling lines with an airway adapter are intended for use with breathing circuits and anesthesia circuits that have an integrated airway adapter. WARNING Patient sampling lines are intended for single-patient use only. Do not clean or disinfect these items. Follow your hospital’s guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. CAUTION The accuracy of the data is greatly influenced by the proper use and fitting of the patient sampling line to ensure proper sampling without the introduction of outside air. To apply the nasal cannula to the patient Step Action Ensure that the nasal cannula is clean, dry and undamaged. Replace the cannula if necessary. Position the cannula on the patient’s face by inserting the nasal prongs into the nostrils. 9‐10 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use Step Action Pass the tubing over the ears and behind the head, ensuring the patient’s head will not rest on any part of the cannula while the patient is lying down. Slide the sleeve toward the patient’s head to assure a good fit of the cannula. Select the Patient Type. See Selecting the Patient Type on page 3‐11. Check that the connections have been made correctly by verifying the patient’s breathing efforts with the displayed CO2 waveform. WARNING Before completion of patient setup, ensure that the patient’s breathing efforts coincide with the displayed CO2 waveform. After allowing the AGS system to run for at least 1 minute, pinch or seal the sampling line for 5 seconds and verify that Occlusion is displayed. If this message does not appear, check all tubing connections for leakage and retest. To apply the sampling line airway adapter Step Expression MR400 Instructions for Use Action Ensure that the sampling line is clean, dry and undamaged. Replace the sampling line if necessary. Monitoring Agents and Gases (AGENT Option) 9‐11 Step Action Place the airway adapter at the proximal end of the airway circuit. CAUTION Always insert the patient sampling line into the water trap port before inserting the airway adapter into the breathing circuit. Failure to follow this may introduce a leak in the circuit, thereby reducing set minute volume. Note Do not place the airway adapter between the ET tube and the elbow as this may allow patient secretions to accumulate in the adapter. If pooling does occur, replace the airway adapter. To prevent moisture from draining into the airway adapter, always place the adapter tubing in a up position, as shown above. Select the Patient Type. See Selecting the Patient Type on page 3‐11. Check that the connections have been made correctly by verifying the patient’s breathing efforts with the displayed CO2 waveform. WARNING Before completion of patient setup, ensure that the patient’s breathing efforts coincide with the displayed CO2 waveform. After allowing the AGS system to run for at least 1 minute, pinch or seal the sampling line for 5 seconds and verify that Occlusion is displayed. If this message does not appear, check all tubing connections for leakage and retest. 9‐12 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use Water Trap Replacement The water trap is intended to protect the AGENT system from humidity, secretions, bacterial contamination and dust. Replacement of the water trap is necessary when the contents in the water trap reach its full line. Water trap Full line CAUTION Always discard the water trap when it becomes filled. Do not attempt to clean or reuse the water trap. Accidental water ingress into the system can affect the gas measurements. Notes • The water trap must be checked every 17 hours of use and replaced as necessary. (Dispose of the trap according to your facility’s biohazard procedure.) • For optimum fit and compatibility, use only Invivo (Royal Philips) specified parts. To replace the water trap Step Action If a sampling line is connected, then remove the sampling line from the sample port on the water trap. Sample port While simultaneously pressing both release tabs on the water trap, remove the water trap from the water trap receptacle then dispose of the water trap properly. Release tabs Water trap receptacle Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐13 Step Action With the new water trap positioned so that the sample port is facing toward you, align the trap’s release tabs to the release tab slots in the water trap receptacle. Press the water trap into the water trap receptacle until audible “clicks” are heard as both of the release tabs lock into the release tab slots. Release tab slots Release tabs Sample port Water trap receptacle Attach the sampling line to the sample port. AGENT and GAS VS Boxes AGENT option measurements are displayed in several areas: • Primary and secondary agent gas measurements are displayed as numeric information in the AGENT VS box. • N2O, O2, and MAC measurements are displayed as numeric information in the GAS VS box. • CO2 measurements are displayed as a waveform in the VS trace area of the screen and as numeric information in the CO2 VS box—where depending upon the RESP > Source setting, CO2‐derived respiration information may appear in the RESP VS box. 9‐14 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use CO2 VS box GAS VS box AGENT VS box RESP VS box Multiple (Mixed) Agents Whenever two or more anesthetic agent gases of detectable concentrations are sensed by the AGS system or when the agent gases in the inspired and end‐tidal breath phases are pure but differ from one another, a multiple agents condition exists and Multiple Agents will be displayed. It is common for a multiple agents condition to occur during the transition from one anesthetic agent to another, such as when one agent is used to induce a patient and another agent is used to maintain the sedated state. Note Some hydrocarbons (for example, acetone or methane) will cause a Multiple Agents alarm to occur. Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐15 AGENT VS Box 5 4 Item Name Definition Alarm flag area Displays AGENT alarm flags when detected; see page 4-31. Secondary agent Et numeric Is the patient’s detected concentration and type of secondary end-tidal agent, in volume percent * Secondary agent Fi numeric Is the patient’s detected concentration and type of secondary fractional inspired agent, in volume percent * Primary agent Et numeric Is the patient’s detected concentration and type of primary end-tidal agent, in volume percent * Primary agent Fi numeric Is the patient’s detected concentration and type of primary fractional inspired agent, in volume percent * AGENT VS box label Indicates the Agent parameter, and accesses the MAC window * Values displayed to the nearest 0.1 percent Notes • No data indication is denoted by three dashes (---) in the agent measurement numeric values (see page 2-20 for an example). When the agent vaporizer is first turned on, it may take 30– 90 seconds for agent identification and readings to be displayed. Once identification is established, changes in concentration readings are virtually immediate. • With a 200 percent change in concentration, an auto zero will occur and full accuracy of the changed concentration will be accomplished within approximately 30 seconds. • For the identified agent gases, these abbreviations (and colors) are used: – Desflurane – Des (light blue) – Enflurane – Enf (orange) – Halothane – Hal (pink) – Isoflurane – Iso (purple) – Sevoflurane – Sev (yellow) 9‐16 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use GAS VS Box Item Name Definition GAS VS box label Indicates the gas parameter MAC numeric Is the total MAC value (see MAC Window on page 9-20) EtN2O numeric Is the patient’s detected end-tidal nitrous oxide concentration in percent FiN2O numeric Is the patient’s detected fractional inspired nitrous oxide concentration in percent FiO2 numeric Is the patient’s detected fractional inspired oxygen concentration in percent Note No data indication is denoted by three dashes (---) in the numeric values (see page 2-20 for an example). When AGENT is turned on, it may take 30–90 seconds for gases identification and readings to be displayed. Once identification is established, changes in concentration readings will be virtually immediate. Changing the AGENT and GAS Alarm Limits The Gas Alarms menu can be accessed by touching the Setup key and then the Alarms key. On the Alarms menu, select the Gas Alarms button. Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐17 Setup key Gas Alarms menu Alarms key Gas Alarms button Lower and upper alarm limit settings for agents and gases are illustrated below. 12 11 10 Sev (Et) – (Sevoflurane [End-tidal]) Sev (Fi) – (Sevoflurane [Fractional inspired]) Des (Et) – (Desflurane [End-tidal]) Des (Fi) – (Desflurane [Fractional inspired]) 9‐18 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use 5 O2 (Fi) – (Oxygen [Fractional inspired]) N2O (Fi) – (Nitrous oxide [Fractional inspired]) Enf (Fi) – (Enflurane [Fractional inspired]) Enf (Et) – (Enflurane [End-tidal]) Iso (Fi) – (Isoflurane [Fractional inspired]) 10 Iso (Et) – (Isoflurane [End-tidal]) 11 Hal (Fi) – (Halothane [Fractional inspired]) 12 Hal (Et) – (Halothane [End-tidal]) Individual alarm limit settings can be adjusted by selecting the parameter that you want to change on the Gas Alarms menu. 123 4 5 Agent or gas alarm limits label (active adjustment shown) Low button Lower alarm limit setting Alarm limit, minimum Upper alarm limit setting Alarm limit, maximum High button Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐19 8 Enter button Current adjustment To change an individual alarm limit setting in the Gas Alarms menu Step Action Touch the agent or gas parameter that you want to change on the Gas Alarms menu. The selection appears on a highlighted background. (HAL [Et] was selected for this example.) Current settings are displayed. Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining setting, repeat steps 2, 3, and 4. The current adjustment will reflect the change. To change any remaining alarm limit settings, repeat steps 1, 2, 3, and 4. Press the Main Screen key to close the menu. Note See chapter 4 for detailed alarm limit setting instructions and options. MAC Window Detected anesthetic vapor strengths of the expired gases contribute to the MAC (Minimum Alveolar Concentration) value and are provided in the MAC window. 9‐20 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use WARNING MAC values are empirical, not absolute values. The MAC values correspond to those of healthy adults and cannot be applied to children. Age and other individual factors influencing the behavior of volatile agents are not taken into account. To open the MAC window Select the AGENT or the GAS VS box (see page 9‐14 for the location). Note If AGENT is set to Single in the System Config menu, the MAC window will display Mixed Agents Not Included In MAC Calculation. Item Name Definition Et Gas Id Is the identifier for the given end-tidal gas Concentration Is the current concentration of the given gas, in percent 1 MAC Is the minimum alveolar concentration for the given gas at which 50 percent of a patient population does not respond with movement to a noxious stimulus, such as skin incision; see table below. Expression MR400 Instructions for Use Gas 1 MAC Value DES (Desflurane) 6.00 volume% ENF (Enflurane) 1.70 volume% HAL (Halothane) 0.77 volume% ISO (Isoflurane) 1.15 volume% SEV (Sevoflurane) 2.10 volume% N2O (Nitrous oxide) 105 percent Monitoring Agents and Gases (AGENT Option) 9‐21 Item Name Definition Is the MAC value that each individual gas contributes to the total MAC value, calculated by C/M, where: # MAC C = the current concentration of the given gas M = the 1 MAC value for the given gas TOTAL MACs Is the total MAC value, which is equal to the sum of the values in the # MAC column, calculated using the following formula: TOTAL MAC = EtN2O / (1 MAC N2O) + (Et 1st Agt) / (1 MAC 1st Agt) + (Et 2nd Agt) / (2 MAC 2nd Agt) Where: • EtN2O = The current value of end-tidal nitrous oxide • 1 MAC N2O = The 1 MAC value for nitrous oxide • Et 1st Agt = The current concentration of the primary agent gas • Et 2nd Agt = The current concentration of the secondary agent gas • 1 MAC 1st Agt = The 1 MAC value for the current primary agent gas • 2 MAC 2nd Agt = The 2 MAC value for the current secondary agent gas CO2 Waveform and VS Box The CO2 measurement is displayed as a waveform in the VS trace area of the screen and as numeric information in the CO2 VS box. Other data, including CO2‐related alarm information, are also provided in this area of the screen. (CO2 [RESP] information can be displayed in the CO2 VS box or in the RESP VS box, as detailed below.) 3 4 5 10 12 9‐22 Monitoring Agents and Gases (AGENT Option) 11 Expression MR400 Instructions for Use Item Name Definition Is the detected CO2 waveform (Trace D) CO2 VS waveform Note To change the waveform speed, see Resp Speed on page 3-25. Alarm flag area Displays CO2 alarm flags when detected; see page 4-31. CO2 VS box label Indicates the CO2 vital sign parameter, and accesses the CO2 menu Unit of measure Indicates that the gas measurement numeric values are given in mmHg (millimeters of mercury) or kPa (kilopascals); see page 9-26. FiCO2 numeric Is the patient’s detected fractional inspired CO2 measurement EtCO2 numeric Is the patient’s detected end-tidal CO2 measurement EtCO2 upper alarm limit Is the upper limit setting for the end-tidal CO2 alarm, and accesses the CO2 (Et) Alarm Limits menu EtCO2 lower alarm limit Is the lower limit setting for the end-tidal CO2 alarm, and accesses the CO2 (Et) Alarm Limits menu Respiration rate upper alarm limit Is the upper limit setting for CO2-derived respiration rate alarm, and accesses the CO2 (RESP) Alarm Limits menu 10 Respiration rate lower alarm limit Is the lower limit setting for CO2-derived respiration rate alarm, and accesses the CO2 (RESP) Alarm Limits menu 11 Respiration rate numeric Is the patient’s detected respiration rate measurement, as derived from CO2 12 Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) When Source is set to BEL in the RESP menu (see page 10-5), the CO2 VS box will also contain CO2-derived respiration rate elements, as indicated by the shaded rows and illustration above; otherwise, this information will be displayed in the RESP VS box (see page 9-25). Changing the CO2 and CO2 (RESP) Alarm Limits The CO2 (Et) and CO2 (Fi) Alarm Limits menu can be accessed by touching the alarm limit settings in the CO2 VS box. Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐23 7 8 9 10 11 6 5 4 3 2 Alarm limit settings, CO2 (Et), CO2 VS box High button Low button CO2 (Et) Alarm Limits menu label (active adjustment shown) CO2 (Fi) Alarm Limits menu label Enter button Current adjustment Alarm limit, minimum Lower alarm limit setting 10 Upper alarm limit setting 11 Alarm limit, maximum To change the CO2 (Et) and CO2 (Fi) alarm limit settings Step Action Select the (Et) CO2 alarm limit settings in the CO2 VS box. The CO2 Alarm Limits menu appears. Current CO2 (Et) settings are displayed. Select the CO2 alarm limits menu, CO2 (Et) or CO2 (Fi), that you want to change. The associated menu appears. Current settings are displayed. Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. 9‐24 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use Step Action Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining settings, repeat steps 2–5. The current adjustment will reflect the change. At the default setting, the CO2 (RESP) Alarm Limits menu can be accessed by touching the alarm limit settings in the RESP VS box. 7 8 10 High button Low button Alarm limit settings, CO2 (RESP), RESP VS box CO2 (RESP) Alarm Limits menu label Enter button Current adjustment Lower alarm limit setting Alarm limit, minimum Upper alarm limit setting 10 Expression MR400 Instructions for Use Alarm limit, maximum Monitoring Agents and Gases (AGENT Option) 9‐25 To change the CO2 (RESP) alarm limit settings Step Action Select the CO2 (RESP) alarm limit settings in the RESP VS box (or, in the CO2 VS box, see page 9‐22.) The CO2 (RESP) Alarm Limits menu appears. Current settings are displayed. Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining setting, repeat steps 2, 3, and 4. The current adjustment will reflect the change. Note See chapter 4 for detailed alarm limit setting instructions and options. Changing the Unit of Measure To change the unit of measure Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) sub‐menu appears. On the Service(Bio‐Med) menu, select System Config. The System Config menu appears. Current settings are displayed. 9‐26 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use Step Action On the System Config menu, select Gas Units. The Gas Units menu appears. The current setting is highlighted. Select the desired unit of measure: mmHg kPa The setting is changed. CO2 Menu The CO2 menu allows you to control the CO2 (Et) and CO2 (RESP) monitoring functions and settings. To open the CO2 menu Select the CO2 VS box. CO2 menu Expression MR400 Instructions for Use CO2 VS box Monitoring Agents and Gases (AGENT Option) 9‐27 The following CO2 menu items are available: Size Grids Zero Cal Note Apnea and Apnea Time will be in the CO2 menu when bellows (BEL) is the selected RESP > Source; see page 10-7 for setting details. To change settings in the CO2 menu Step Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. Touch the menu item to select one of the following CO2 options: Size Grids Zero Cal The menu item appears. The current setting is highlighted. Select the desired setting from the menu options (except Grids, which is selectable on the CO2 menu). The setting is entered. To change other settings, repeat steps 2 and 3. Size Controls the size of the CO2 waveform. The following options are available: • 40 mmHg (Default) • 60 mmHg • 80 mmHg 9‐28 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use To adjust the grid size for the CO2 waveform Step Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. Select Size. The Size menu appears. The current setting is highlighted. Select the desired size: 40 mmHg 60 mmHg 80 mmHg The setting is changed. Grids Displays a scaled grid, which is graduated according to the Size selection for the CO2 waveform. Size Grid The following options are available: • Off does not display a grid. (Default) • On displays a grid. Note Grids will not be displayed during a CO2 Accuracy Check; see page 3-30. Expression MR400 Instructions for Use Monitoring Agents and Gases (AGENT Option) 9‐29 To control the display function of the CO2 grid Step Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. Locate Grids and select the desired setting: Off On The setting is entered. Zero Cal Initiates a zero calibration (an automatic function during normal use) of the CO2 system to allow for the different characteristics of each accessory type. Zero Cal is not required when switching sampling lines. The maximum time required for calibration is approximately 10–12 seconds. To perform a zero calibration See page 9‐2. 9‐30 Monitoring Agents and Gases (AGENT Option) Expression MR400 Instructions for Use CHAPTER 10 Monitoring RESP When equipped with the CO2 or AGENT option, the patient’s respiration rate can be measured as the time interval between detected breaths. Alternatively, the patient’s respiration rate can be measured using the pneumatic bellows and the wSpO2 module. Patient Preparation for RESP Monitoring When preparing a patient, the monitoring method used will impact the performance and operation of the RESP parameter. Monitoring Respiration using CO2 CO2‐derived respiration is calculated by measuring the time interval between detected breaths; see chapter 7 (if equipped with the LoFlo option) or chapter 9 (if equipped with the AGENT option) for detailed monitoring information. For RESP VS box functions when CO2‐derived respiration is the source, see page 10‐3. Monitoring Respiration using the Bellows Bellows‐derived respiration is monitored by detecting abdominal or chest wall motion using the pneumatic bellows device (REF 989803152791) and the wSpO2 module. The bellows may be used in the MR system bore, although the module must not be placed within the MR system bore. Note that there are no alarms for the bellows‐derived respiration rate as it is not intended for vital sign monitoring. CAUTION If dropped, the wSpO2 module must be verified for correct operation before use; see page 14-12. Note If bellows respiration is turned on while the CO2 is on, bellows respiration rate data will appear in the RESP VS box and CO2 respiration rate data will appear in the CO2 VS box. Expression MR400 Instructions for Use Monitoring RESP 10‐1 Bellows Preparation Respiration measurements that are determined using the bellows method make chest wall expansion very important for accurate monitoring of a patient’s breathing. If the respiratory signal appears to weaken between scans, instruct the patient to breathe more deeply during the scan to create more movement at the sensor site. CAUTIONS • Avoid excessive bending of the flexible hose, as this can impair respiration detection. • Always apply the bellows to the patient prior to connecting the pneumatic respiration hose to the port on the wSpO2 module; otherwise damage to the module can result. To position the respiratory sensor Step Action Place the sensor on the patient’s upper abdomen or lower chest (whichever expands most during inspiration). After the patient has exhaled, place the velcro strap around the patient’s trunk and secure the sensor snuggly. Connect the flexible hose from the bellows to the pneumatic respiration port on the wSpO2 module. wSpO2 module Pneumatic respiration port Flexible hose Check the battery indicator on the wSpO2 module to ensure that enough charge exists: • Green battery indicator = Charge sufficient; proceed to step 6. • Red battery indicator = Charge low; proceed to step 5. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) 10‐2 Monitoring RESP Insert a charged module battery into the wSpO2 module and then recheck the battery indicator to ensure a sufficient charge before proceeding; see page 1‐26. Expression MR400 Instructions for Use Step Action Check the network channel indicator on the wSpO2 module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 7. • Flashing = No communication; proceed to step 6. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Ensure that the wSpO2 module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. Select the Patient Type. See Selecting the Patient Type on page 3‐11. Ensure that the parameter is working by checking the displayed respiratory numeric in the VS box. 10 Position the patient in the MR system, keeping the wSpO2 module outside the MR system bore. Ensure that the flexible hose is routed away from any moving parts so that it does not get caught in the mechanisms (for example, between the tabletop and the patient support). 11 Place the wSpO2 module on a cushioned surface to minimize MR vibrations. Respiration VS Box Depending upon the Source selection, respiration measurements are displayed as numeric information in the RESP VS box. Other data, including respiration‐related alarm information, are also provided in this area of the screen, as detailed below. Expression MR400 Instructions for Use Monitoring RESP 10‐3 • When RESP > Source > CO2 is selected, the CO2‐derived respiration measurement and alarm limit settings (displayed in the same color as the CO2 VS box data) will populate the RESP VS box. Item Name Definition Alarm flag area Displays CO2 (RESP) alarm flags when detected; see page 4-31. Respiration rate upper alarm limit Is the upper limit setting for the CO2 (RESP) alarm, and accesses the CO2 (RESP) Alarm Limits menu (when Source is CO2) Respiration rate lower alarm limit Is the lower limit setting for the CO2 (RESP) alarm, and accesses the CO2 (RESP) Alarm Limits menu (when Source is CO2) Source label Is the source used for the respiration monitoring, where CO2 is CO2-derived; see page 10-7 Respiration rate numeric Is the patient’s detected respiration rate measurement Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) RESP VS box label Indicates the respiration vital sign parameter, and accesses the RESP menu • When RESP > Source > BEL is selected, the bellows‐derived respiration measurement (displayed in white) will populate the RESP VS box. Item Name Definition Indicates the respiration parameter, and accesses the RESP menu RESP VS box label 10‐4 Monitoring RESP Expression MR400 Instructions for Use Item Name Definition Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) Respiration rate numeric Is the patient’s detected respiration rate measurement Source label Is the source used for the respiration monitoring, where BEL is bellows-derived; see page 10-7 Changing the CO2 (RESP) Alarm Limits To change the CO2 (RESP) alarm limit settings: • If equipped with the CO2 LoFlo option, see page 7‐9. • If equipped with the AGENT option, see page 9‐23. RESP Menu RESP menu items allow you to control respiration functions and settings. To open the RESP menu Select the RESP VS box. Expression MR400 Instructions for Use Monitoring RESP 10‐5 RESP menu RESP VS box The following RESP menu items are available:. Source Apnea Apnea Time Note If RESP > Source > BEL, then Apnea and Apnea Time will be in the CO2 menu. To change settings in the RESP menu Step Action Select the RESP VS box. The RESP menu appears. Current settings are displayed. 10‐6 Monitoring RESP Expression MR400 Instructions for Use Step Action Touch the menu item to select one of the following RESP options: Source Apnea Apnea Time The menu item appears. The current setting is highlighted. Select the desired setting from the menu options (except Apnea, which is selectable on the RESP menu). The setting is entered. To change other settings, repeat steps 2 and 3. Source Selects the source used to acquire the respiration rate measurements displayed the RESP VS box. The following options are available: • CO2 calculates the rate by measuring the time interval between detected breaths. (Default, when equipped with the CO2 or AGENT option) • BEL calculates the rate using a pneumatic bellows that measures chest or abdominal movement. No waveform is provided. (If equipped with the CO2 or AGENT option, then the CO2 respiration rate elements will appear in the CO2 VS box.) To control the source used for respiration Step Action Select the RESP VS box. The RESP menu appears. Current settings are displayed. Select Source. The Source menu appears. The current setting is highlighted. Select the desired setting for the respiration rate source: CO2 BEL The setting is changed. Expression MR400 Instructions for Use Monitoring RESP 10‐7 Apnea WARNING The respiration measurement does not recognize obstructive and mixed apneas—it only indicates an alarm when a pre-adjusted time has elapsed since the last detected breath. The safety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established. Controls the apnea alarm function, which is declared when the pre‐adjusted time (see Apnea Time, below) has elapsed since the last breath was detected. Determined from CO2 only, not bellows. Once activated, the alarm will be deactivated when the respiration rate goes above zero. The following options are available: • Off does not report an apnea alarm. • On reports an apnea alarm when detected. (Default) To control the apnea alarm function Step Action Select the RESP VS box. The RESP menu appears. Current settings are displayed. Locate Apnea and select the desired setting: Off On The setting is entered. Apnea Time Sets the amount of time to wait before declaring that the apnea condition exists. The following options (in seconds) are available: 10‐8 Monitoring RESP • 20 Sec (Default) • 25 Sec • 30 Sec • 35 Sec • 40 Sec Expression MR400 Instructions for Use To set the apnea time delay Step Action Select the RESP VS box. The RESP menu appears. Current settings are displayed. Ensure that Apnea is On. If Apnea is not On, enable the setting as described on page 10‐8. Select Apnea Time. The Apnea Time menu appears. The current setting is highlighted. Select the desired time delay (in seconds) for the alarm indication: 20 Sec 25 Sec 30 Sec 35 Sec 40 Sec The setting is changed. Expression MR400 Instructions for Use Monitoring RESP 10‐9 10‐10 Monitoring RESP Expression MR400 Instructions for Use CHAPTER 11 Monitoring Temperature When equipped with the temperature option, the patient’s surface or body temperature can be monitored using the reusable sensor, FlexTEMP II Sensor (Esophageal/Rectal/Axillary, Direct Mode), REF 989803194511. The FlexTEMP II Sensor (Esophageal/Rectal/Axillary, Direct Mode), hereafter referred to as the temperature sensor, is designed specifically for use with MR400. The components of the temperature sensor are shown below. Sensing tip Leader Connector Jacket retainer Patient segment General Usage Precautions WARNINGS • Only use specified temperature accessories as other types or brands may compromise the safety and accuracy of the MR400. Patient injury or loss of monitoring may result if incorrect accessories are used. • During long term monitoring sessions (4 hours or more), frequent medical attention must be given to the sensor site for possible pressure tissue necrosis, especially on the tender skin of neonatal patients. Expression MR400 Instructions for Use Monitoring Temperature 11‐1 CAUTION The sensor contains no latex, and is constructed of fiber-optic glass. Always handle the sensor with care to prevent damage, as improper handling can result in inaccurate readings. Never bend any portion of the sensor into a radius of less than 15 mm (0.6 inches). You should observe the following general precautions when using the temperature sensor: • Ensure that only the FlexTEMP II Sensor (Esophageal/Rectal/Axillary, Direct Mode), REF 989803194511—and if needed sensor jackets (REF 989803178181)—are used with the MR400. • Never immerse the entire sensor in liquid. • Never sterilize the sensor. • Do not tangle, pull or apply excessive force or tension to any portion of the sensor. • Do not expose the sensing tip to temperatures above 50°C (122°F). • Do not alter or modify the sensor, as this can affect performance and accuracy and void the warranty. • Never use strong solvents such as acetone, freon or other industrial cleaners on the sensor. • After each cleaning and before each use, inspect the sensor for damage (cracks, holes, tears, cuts, et cetera) and always discard a damaged sensor. Initial Use Always handle the temperature sensor with care. Upon receiving the temperature sensor, thoroughly clean and disinfect the device before using it on a patient. Use soap and water and CaviWipes® disinfectant towelettes and the suggested method to clean and disinfect the sensor, as the warranty does not cover damage caused by unapproved substances or methods; see Cleaning, Disinfecting and Inspecting the Accessories, on page 14‐7, for details. Afterward, connect the sensor to the MR400. CAUTION The temperature sensor is sold non-sterile. 11‐2 Monitoring Temperature Expression MR400 Instructions for Use Connecting and Disconnecting the Sensor CAUTION When inserting or removing the temperature sensor from the MR400, only use the connector and never pull or apply excessive force or tension to any other portion of the device. To connect the temperature sensor Grasp the sensor connector then align the connector to the temperature port on the MR400 and push the connector forward until you feel or hear it “click” into place. Temperature port Sensor connector Accessory hook To store the temperature sensor When not in use, loosely loop the sensor and then drape it over an accessory hook. To disconnect the temperature sensor from the MR400 Grasp the sides of the connector, and then pull the connector out of the temperature port. Expression MR400 Instructions for Use Monitoring Temperature 11‐3 Temperature Measurements Depending upon the monitoring method (surface or body), follow the corresponding procedure below to make a temperature measurement. Allow at least 2 minutes for measurement stabilization, with or without the sensor cover (jacket). Note A temperature difference exists between a patient’s surface temperature and body temperature. Making Surface Temperature Measurements When making surface temperature measurements, place the temperature sensor at an axillary site according to the steps below. To make surface temperature measurements Step Action Carefully uncoil the sensor, using care to avoid knotting or kinking the device. Clean and disinfect the sensor; see Cleaning, Disinfecting and Inspecting the Accessories, on page 14‐7, for details. Thoroughly clean and dry the patient’s axillary application site. WARNING Do not place the sensor on or near an open wound. Failure to comply may result in patient infection. 11‐4 Monitoring Temperature Position the sensing tip of the sensor at the axillary site then apply it to the patient. If desired, change the unit of measure (Celsius is the default setting); see TEMP Menu, on page 11‐10, for details. Perform the monitoring procedure, allowing at least 2 minutes for the measurement to stabilize; see TEMP VS Box, on page 11‐8, for details. After the procedure, remove the sensor from the patient. Immediately clean and disinfect the sensor (see Post‐Measurement Processing on page 11‐7). Expression MR400 Instructions for Use Making Body Temperature Measurements FlexTEMP System Jackets are mandatory for use with the temperature sensor when making esophageal or rectal (body) temperature measurements. Before making temperature measurements at esophageal or rectal sites, cover the sensor according to the steps below. WARNINGS • Use of FlexTEMP System Jackets are mandatory when using the sensor for body (i.e., esophageal or rectal) site temperature measurements. Failure to comply may result in patient infection. • Always use a new jacket if a different placement area is desired. Once the sensor has been used for esophageal or rectal placement, do not change the location unless a new jacket is installed as patient injury or infection could result. • Do not reuse a FlexTEMP System Jacket, as they are designed for single-use only. Failure to comply may result in patient infection. Placing the Temperature Sensor in a Jacket FlexTEMP System Jackets are sterile polyurethane sensor covers and should be handled accord‐ ingly. For optimal storage, jackets should remain sealed in sterile packs in closed cabinets where a moderate temperature and low humidity are maintained. When placing the sensor in a jacket, ensure that the sensing tip is fully inserted and that the jacket tabs extend over the patient seg‐ ment of the temperature sensor, as described in the steps below. To place the temperature sensor in a jacket Step Expression MR400 Instructions for Use Action Carefully uncoil the sensor, using care to avoid knotting or kinking the device. Clean and disinfect the sensor; see Cleaning, Disinfecting, and Inspecting the Accessories, on page 14‐7, for details. Open the indicated end of a jacket package enough to expose the jacket tabs. Insert the patient segment of the sensor into the jacket. Grasp the jacket tabs then carefully pull the jacket completely over the patient segment of the sensor. Monitoring Temperature 11‐5 Step Action Ensure that the patient segment of the sensor is completely inserted. There should be no excess space at jacket tip and the jacket tabs should extend over the sensor’s jacket retainer. Jacket tabs Patient segment Jacket retainer Jacket tip If needed, secure the jacket tabs to the jacket retainer using medical tape. Follow the steps below to make a body temperature measurement. When ready to apply the sensor to the patient, peel the jacket package open and remove the jacketed sensor, using care not to soil the sterilized jacket. For sensor placement instructions, see Placing the Sensor at the Body Site, below. Placing the Temperature Sensor at the Body Site WARNING When inserting the sensor into the mouth, use care not to scrape or tear the jacket on the patient’s teeth and ensure that the patient does not bite the sensor, as this could expose the sensor and compromise the infection control features of the jacket. Note During MRI procedures a large amount of radio frequency (RF) energy is present, which may cause a patient’s body temperature to increase. When making body temperature measurements, place the covered sensor at the esophageal or rectal site according to the steps below. 11‐6 Monitoring Temperature Expression MR400 Instructions for Use To make body temperature measurements Step Action Ensure that a jacket has been placed on the sensor (see Placing the Sensor in a Jacket, on page 11‐5). If needed, apply lubricant to the jacket for insertion into the patient. CAUTION Never use petroleum-based lubricants. A water-based lubricant (for example, Surgical Lubricant, REF 989803168891) can be used to facilitate insertion. Insert the sensing tip of the sensor into the patient at an appropriate depth. WARNING Never insert the sensor beyond the patient segment of the sensor. Insertion beyond the patient segment can lead to difficulties removing the jacket from the patient. If desired, change the unit of measure (Celsius is the default setting); see TEMP Menu, on page 11‐10, for details. Perform the monitoring procedure, allowing at least 2 minutes for the measurement to stabilize; see TEMP VS Box, on page 11‐8, for details. After the procedure, remove the sensor from the patient. WARNING Ensure that the entire jacket is removed from the patient when withdrawing the sensor. Failure to do so can potentially lead to jacket material being left inside the patient. Immediately clean and disinfect the sensor (see Post‐Measurement Processing on page 11‐7). Post-Measurement Processing After monitoring temperature, process the sensor as follows. Expression MR400 Instructions for Use Monitoring Temperature 11‐7 To process the temperature sensor after use Step Action If a jacket was placed on the sensor, remove the jacket and any medical tape (if used). Refer to your facility’s biohazard procedure for disposal of used jackets and medical tape. Typically, jackets and tape are disposed of as medical waste per facility procedures due to contamination concerns. Thoroughly clean and disinfect the sensor; see Cleaning, Disinfecting, and Inspecting the Accessories, on page 14‐7, for details. Store the sensor; see Connecting and Disconnecting the Sensor, on page 11‐3, for details. Accuracy Check No calibration of the temperature sensor is required. If the accuracy of a measurement is in question or if a problem is suspected with the temperature option, perform the user routine‐ tests; see chapter 14. TEMP VS Box The temperature measurement is displayed as numeric information in the TEMP VS box. Other data, including temperature‐related alarm information, are also provided in this area of the screen, as detailed below. Item Name Definition Displays TEMP alarm flags when detected; see page 4-31. Alarm flag area 11‐8 Monitoring Temperature Expression MR400 Instructions for Use Item Name Definition Temperature upper alarm limit Is the upper limit setting for the TEMP alarm, and accesses the TEMP Alarm Limits menu Temperature lower alarm limit Is the lower limit setting for the TEMP alarm, and accesses the TEMP Alarm Limits menu Temperature numeric Is the patient’s detected temperature measurement Unit of measure Indicates that the temperature numeric is given in degrees Celsius (°C) or degrees Fahrenheit (°F) TEMP VS box label Indicates the temperature vital sign parameter, and accesses the TEMP menu Changing the TEMP Alarm Limits The TEMP Alarm Limits menu can be accessed by touching the alarm limit settings in the TEMP VS box. 7 8 10 Expression MR400 Instructions for Use Alarm limit settings, TEMP VS box Enter button Current adjustment TEMP Alarm Limits menu label Alarm limit, minimum Lower alarm limit setting Upper alarm limit setting Alarm limit, maximum High button 10 Low button Monitoring Temperature 11‐9 Changing the Unit of Measure To change the unit of measure Step Action Select the TEMP VS box. The TEMP menu appears. Current settings are displayed. Select Units. The Units menu appears. The current setting is highlighted. Select the desired unit of measure: °C °F The setting is changed. TEMP Menu The TEMP menu item allows you to control the unit of measure for temperature. To open the TEMP menu Select the TEMP VS box. TEMP menu TEMP VS box 11‐10 Monitoring Temperature Expression MR400 Instructions for Use The following TEMP menu items are available: Units Units Selects the unit of measure used for presentation of the temperature numeric data. The following options are available: • °C (Default) • °F To select the unit of measure for temperature See Changing the Unit of Measure on page 11‐10. Expression MR400 Instructions for Use Monitoring Temperature 11‐11 11‐12 Monitoring Temperature Expression MR400 Instructions for Use CHAPTER 12 Monitoring NIBP The NIBP (non‐invasive blood pressure) parameter measures and displays systolic, diastolic and mean arterial pressures. Alarm limit settings are available for all three pressures. When using NIBP to measure blood pressure, readings are not continuous but are updated each time a blood pressure measurement is taken. Set a shorter interval when frequent updating of the patient’s blood pressure is needed. Visually checking the patient, confirming NIBP measurements against other vital sign measurements and attention to the limb where the cuff is attached must be standard routines during NIBP use. Adult and pediatric blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, manual, electronic, or automated sphygmomanometers. This monitor uses the oscillometric method for measuring NIBP. Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques. In adult and pediatric mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (IEC 80601‐2‐30:2011) in relation to mean error and standard deviation, when compared to intra‐ arterial or auscultatory measurements (depending on the configuration) in a representative patient population. For the auscultatory reference, the fifth Korotkoff sound was used to determine the diastolic pressure. In neonatal mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (IEC 80601‐2‐ 30:2011) in relation to mean error and standard deviation, when compared to intra‐arterial measurements in a representative patient population. Neonatal blood pressure measurements determined with this device are equivalent to those obtained by an intra‐arterial blood pressure measurement device, within the limits prescribed by the American National Standard, manual, electronic, or automated sphygmomanometers. WARNINGS • Use clinical judgment to decide whether to perform a repeated series of NIBP measurements because of the risk of purpura, ischemia and neuropathy in the limb with the NIBP cuff. • Arrhythmias, erratic heartbeats and patient motion can result in inaccurate readings and/or prolonged measurements. If questionable readings are obtained, check the patient’s vital signs by alternate means before administering medication. • The performance of the automated sphygmomanometer can be affected by extremes of temperature, humidity and altitude. Expression MR400 Instructions for Use Monitoring NIBP 12‐1 CAUTIONS • Substitution of components or accessories different from those supplied or recommended can result in measurement errors. • NIBP accuracy has not been verified in the presence of some common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation. Patient Preparation for NIBP Monitoring WARNINGS • The NIBP cuff inflation rate may increase and the initial pressure may increase up to 180 mmHg when changing the patient type. • Patient Category: Select the correct patient category setting for your patient. Do not apply the higher adult inflation, overpressure limits and measurement duration to neonatal patients as this may result in inaccurate readings or patient injury. The Patient Type should be selected, as this setting determines the inflation pressures of the NIBP cuff, reading times and appropriate alarm limit range. When positioning the patient, routine NIBP measurements (including for the condition hypertension) require the patient to remain silent, still and relaxed, with legs uncrossed and arms supported. Note that during MRI procedures, patients are typically laying down with their legs uncrossed and arms supported as needed for the MRI scan, and a 5‐minute waiting period is also recommended before starting readings. Ensure that the cuff is at the level of the right atrium of the heart. In some cases, a patient may exhibit a low pulse amplitude due to any of the following conditions. The list provides only some examples of potential causes of low pulse amplitudes that can make NIBP difficult to measure in a convenient and timely manner: 12‐2 Monitoring NIBP • Medication • Sedation • Disease or illness • Physiological or neurological conditions • Obesity (or any occurrence of metabolism with extreme variations) • Stress • Size Expression MR400 Instructions for Use CAUTION There may be occasions when a particular mode is not suitable for its apparent category of patients based on age alone. In these cases, a clinical decision shall be made to use another patient type, NIBP cuff size or measurement technique. The clinical decision shall be based on all of the factors listed in Determining the Patient Type (see page 3-11) to ensure the best possible and most timely NIBP measurement acquisition. Note Adult and Pediatric types dictate use of a larger NIBP cuff and interconnect hose size, while Neo uses smaller sizes; see the cuff and hose information on page 1-36. Selecting the NIBP Cuff WARNING To ensure accurate reliable measurements, use only the recommended NIBP accessories. Use the appropriate NIBP cuff size for each patient, as recommended by the current American Heart Association guidelines for blood pressure monitoring, to ensure safety and accuracy. A wide variety of NIBP cuffs and interconnect hoses are available for your monitoring needs; see page 1‐36 for details. The NIBP cuff should be selected as it would be for an auscultatory blood pressure determination. The current guidelines of the American Heart Association must be followed. Expression MR400 Instructions for Use Monitoring NIBP 12‐3 The bladder width of the cuff must be 40 percent of the circumference of the limb. It is also advisable to keep the air volume to a minimum by using the smallest cuff size possible for each patient. The point of maximum oscillations is coincident with mean arterial pressure regardless of arterial elasticity so long as the ratio of air volume in the cuff to the volume of the artery under compression does not greatly exceed ten (10) to one (1). Index line Circumference range For a correct NIBP cuff fit: • Adult and pediatric patients—the index line on the size chosen should fall within the range line when placed on the patient. • Neonatal patients—the size chosen should be within the stated circumference range for the limb of the neonate. • All patients—align the cuff to ensure the artery mark is placed over the artery. • All patients—the middle of the cuff should be placed at the level of the right atrium of the heart. Range line Artery mark NIBP cuff WARNING Single use devices, as indicated on the device packaging, should be disposed of after use and must never be reused. Follow your hospital’s guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. 12‐4 Monitoring NIBP Expression MR400 Instructions for Use Positioning the NIBP Cuff WARNINGS • Avoid compression, kinking or restriction of the NIBP cuff hose, as the effect of blood flow interference can result in patient injury caused by continuous cuff pressure. • Do not use the NIBP cuff on a limb with an intravenous infusion or where an arterial catheter or arterio-venous (A-V) shunt is in place because of temporary interference to blood flow. This could result in injury to the patient. • Do not place the NIBP cuff over a wound, as this can cause further injury. • Do not place the NIBP cuff on the same or adjacent arm to a mastectomy, or where the lymph nodes were removed, or if a shunt is on that arm. This can lead to bruising, inaccurate readings, or negatively impact the drainage of fluids because of temporary interference to blood flow. The NIBP cuff should be positioned as it would be for an auscultatory blood pressure determination. The current guidelines of the American Heart Association must be followed. Wrap the NIBP cuff firmly (not snuggly) around the arm or leg of the patient, making sure that the cuff is at the approximate level of the heart to ensure accuracy of the obtained values. Connecting the NIBP Cuff WARNING Routinely inspect the NIBP cuff and hose assemblies for proper connection and orientation. Replace accessories that have cracks, holes, tears, or cuts that could cause leaks in the system. If such damaged NIBP cuff or hose assemblies are used, prolonged and/or inaccurate patient readings could result. To connect the NIBP cuff and hose Step Action Insert the appropriate interconnect hose connector onto the NIBP port. Push the hose connector forward and then turn it clockwise. NIBP port Expression MR400 Instructions for Use Monitoring NIBP 12‐5 Step Action Attach a NIBP cuff appropriate for the patient type and size to the interconnect hose. Position the cuff on the patient; see page 12‐5. Ensure that the cuff and interconnect hoses are not kinked. Choosing the Measurement Mode NIBP measurements can be taken automatically or manually, using the mode that best suits the needs of your patient. The following are frequently used functions related to NIBP; also refer to page 12‐14 for other NIBP functions. Making Automatic Measurements You can automatically measure a patient’s blood pressure at predefined intervals, which are measured from the start of one NIBP measurement to the start of the next. To turn on automatic operation Step Action Select the Patient Type. See Selecting the Patient Type on page 3‐11. Press the NIBP Interval key. The Interval menu appears. The current setting is highlighted. Select the desired minute(s) for the interval: 1 Min 2 Min 3 Min 5 Min 10 Min 15 Min 20 Min 30 Min The selection is entered. 12‐6 Monitoring NIBP Expression MR400 Instructions for Use Step Action Select the NIBP VS box. On the NIBP menu, toggle Auto Mode to On. To begin automatic operation, press the NIBP Start/Stop key. Making Manual Measurements You can manually define the measurement interval of a patient’s blood pressure. To control manual operation Step Action Select the Patient Type. See Selecting the Patient Type on page 3‐11. To start or stop the measurement, press the NIBP Start/Stop key. Initial Inflation Pressures and Reading Durations WARNINGS • Performing NIBP measurements too frequently can cause injury to the patient due to blood flow interference. • Always monitor the NIBP cuff site (for example, by observation of the limb concerned) to ensure that operation of the automated sphygmometer does not result in prolonged impairment of the circulation of the blood of the patient. • Pressurization of the NIBP cuff can temporarily cause loss of function of simultaneously used monitoring ME equipment on the same limb. The initial inflation pressure is the amount that the NIBP cuff will inflate for the first NIBP measurement: • Adult is used for most adult patients: Initial inflation pressure: 165 ± 15 mmHg • Pediatric is used for any patient exhibiting low pulse amplitudes (a condition exhibited by pediatric‐size patients): Initial inflation pressure: 130 ± 15 mmHg • Neo is used for most neonatal patients: Initial inflation pressure: 100 ± 15 mmHg When subsequent NIBP measurements are taken on the same patient (and if not in suspend mode), the monitor adjusts the inflation value up or down based on the previous reading results. Expression MR400 Instructions for Use Monitoring NIBP 12‐7 Stopping an NIBP Measurement Press the NIBP Start/Stop key to stop a reading cycle. Suspend Mode during NIBP Measurements When the Suspend key is pressed, NIBP functions will be affected as follows: • Any reading in progress will be stopped. • The system will pump to the initial inflation pressure for the selected patient type. • Manual readings can be taken. • Auto readings cannot be taken. • The “NEXT” timer will not run. • When exiting Suspend Mode, any manual reading will not be stopped. NIBP VS Box The NIBP measurements are displayed as numeric information in the NIBP VS box. Other data, including NIBP‐related alarm information, are also provided in this area of the screen, as detailed below. Note Depending upon the selected Format (see page 12-17) of the data, the elements contained in the NIBP VS box are displayed in the Systolic/Diastolic format or in the Mean format. Systolic/Diastolic Format 12 11 10 12‐8 Monitoring NIBP 7 6 54 Expression MR400 Instructions for Use Item Name Definition Alarm flag area Displays NIBP alarm flags when detected; see page 4-31. Dia upper alarm limit Is the upper limit setting for the diastolic alarm, and accesses the NIBP Alarm Limits menu Dia lower alarm limit Is the lower limit setting for the diastolic alarm, and accesses the NIBP Alarm Limits menu Sys lower alarm limit Is the lower limit setting for the systolic alarm, and accesses the NIBP Alarm Limits menu Sys upper alarm limit Is the upper limit setting for the systolic alarm, and accesses the NIBP Alarm Limits menu Mean numeric Is the patient’s detected mean pressure measurement Diastolic numeric Is the patient’s detected diastolic pressure measurement Systolic numeric Is the patient’s detected systolic pressure measurement Unit of measure Indicates that the NIBP measurement numeric values are given in mmHg (millimeters of mercury) or kPa (kilopascals) 10 Elapsed time / cuff pressure Is the time since the last completed NIBP reading, in the following format: : : , where = Two-digit hours field = Two-digit minutes field = Two-digit seconds field Note During a reading, this displays the cuff pressure. 11 Auto Mode setting Indicates Manual when in manual mode; or, Next when in automatic mode along with the time until the next NIBP measurement, displayed in the following format: : : , where = Two-digit hours field = Two-digit minutes field = Two-digit seconds field 12 NIBP VS box label Expression MR400 Instructions for Use Indicates the NIBP vital sign parameter, and accesses the NIBP menu Monitoring NIBP 12‐9 Mean Format 10 9 8 Item Name Definition Alarm flag area Displays NIBP alarm flags when detected; see page 4-31. Mean upper alarm limit Is the upper limit setting for the mean alarm, and accesses the NIBP Alarm Limits menu Mean lower alarm limit Is the lower limit setting for the mean alarm, and accesses the NIBP Alarm Limits menu Mean numeric Is the detected patient’s mean pressure measurement Diastolic numeric Is the patient’s diastolic pressure measurement Systolic numeric Is the patient’s systolic pressure measurement Unit of measure Indicates that the NIBP measurement numeric values are given in mmHg (millimeters of mercury) or kPa (kilopascals); see Pressure Units in the System Config menu on page 3-30. Elapsed time / cuff pressure Is the time since the last completed NIBP reading, in the following format: : : , where = Two-digit hours field = Two-digit minutes field = Two-digit seconds field Note During a reading, this displays the cuff pressure. 12‐10 Monitoring NIBP Expression MR400 Instructions for Use Item Name Definition Indicates Manual when in manual mode; or, Next when in automatic mode along with the time until the next NIBP measurement, displayed in the following format: Auto Mode setting : : , where = Two-digit hours field = Two-digit minutes field = Two-digit seconds field 10 NIBP VS box label Indicates the NIBP vital sign parameter, and accesses the NIBP menu Changing the NIBP Format To control the format of the NIBP data Step Action Select the NIBP VS box. The NIBP1 menu appears. Current settings are displayed. Select Format. The Format menu appears. The current setting is highlighted. Select the desired format: SysDia Mean The format is changed. Changing the Unit of Measure Note When using an IP5 and Pressure Units is changed, the displayed formatting of the value and placement of the decimal point is changed immediately. However, it can take up to 2 seconds for the measurement numeric values to reflect the new unit of measure. Do not print or perform data captures during this period. Expression MR400 Instructions for Use Monitoring NIBP 12‐11 To change the unit of measure Step Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) menu appears. On the Service(Bio‐Med) menu, select System Config. The System Config menu appears. Current settings are displayed. On the System Config menu, select Pressure Units. The Pressure Units menu appears. The current setting is highlighted. Select the desired setting: mmHg kPa The setting is entered. Changing the NIBP Alarm Limits The NIBP Alarm Limits menu can be accessed by touching the alarm limit settings in the NIBP VS box. 56 10 11 12 12‐12 Monitoring NIBP Alarm limit settings, NIBP VS box Enter button Current adjustment NIBP Systolic Alarm Limits menu label (active adjustment shown) Expression MR400 Instructions for Use 5 Alarm limit, minimum Lower alarm limit setting Upper alarm limit setting Alarm limit, maximum High button 10 Low button 11 NIBP Diastolic Alarm Limits menu label 12 NIBP Mean Alarm Limits menu label To change the NIBP alarm limit settings Step Action Select the alarm limit settings in the NIBP VS box. The NIBP Alarm Limits menu appears. Current settings are displayed. Select the desired pressure: NIBP (Sys) NIBP (Dia) NIBP (Mean) The pressure is selected. Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the change. Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining settings, repeat steps 2, 3, 4 and 5. The current adjustment will reflect the change. Note See chapter 4 for detailed alarm limit setting instructions and options. Expression MR400 Instructions for Use Monitoring NIBP 12‐13 NIBP Menu The NIBP menu allows you to control non‐invasive blood pressure functions and settings. To open the NIBP menu Select the NIBP VS box. NIBP menu NIBP VS box The following NIBP menu items are available:. Interval Auto Mode Format To change settings in the NIBP menu Step Action Select the NIBP VS box. The NIBP menu appears. Current settings are displayed. 12‐14 Monitoring NIBP Expression MR400 Instructions for Use Step Action Touch the menu item to select one of the following NIBP options: Interval Auto Mode Format The menu item appears. The current setting is highlighted. Select the desired setting from the menu options (except Auto Mode, which is selectable on the NIBP menu). The setting is entered. To change other settings, repeat steps 2 and 3. Interval Sets the interval for automatic NIBP measurements. The following options are available: • 1 Min • 2 Min • 3 Min (Default) • 5 Min • 10 Min • 15 Min • 20 Min • 30 Min To set the interval for NIBP readings Step Action Select the NIBP VS box. The NIBP menu appears. Current settings are displayed. Expression MR400 Instructions for Use Monitoring NIBP 12‐15 Step Action Select Interval. The Interval menu appears. The current setting is highlighted. Select the desired minute(s) for the interval: 1 Min 2 Min 3 Min 5 Min 10 Min 15 Min 20 Min 30 Min The setting is changed. Auto Mode Sets the mode used to take NIBP readings. Note A manual reading will not restart this cycle time. The following options are available: • Off takes readings manually (Manual mode), where readings are initiated by pressing the NIBP Start/Stop key; see Making Manual Measurements on page 12‐7 for details. (Default) • On takes readings automatically, where when selected (or since leaving suspend mode), the first reading must be initiated by pressing the NIBP Start/Stop key and then all subsequent readings will be taken at the selected interval; see Making Automatic Measurements on page 12‐6 for other setup details. To set the mode for NIBP readings Step Action Select the NIBP VS box. The NIBP menu appears. Current settings are displayed. Locate Auto Mode and select the desired setting: Off On The setting is entered. 12‐16 Monitoring NIBP Expression MR400 Instructions for Use Format Sets the displayed format of the NIBP numeric data. The following options are available: • SysDia displays the systolic and diastolic numerics in a large font separated by a slash and the mean numeric will be in a smaller font bracketed with parenthesis. (Default) • Mean displays the mean measurement numeric in a large font, and the systolic and diastolic measurement numeric values in a smaller font and separated by a slash. To control the format of the NIBP data See Changing the NIBP Format on page 12‐11. Expression MR400 Instructions for Use Monitoring NIBP 12‐17 12‐18 Monitoring NIBP Expression MR400 Instructions for Use CHAPTER 13 Trend Data and Printing Trending Functions The MR400 provides versatile trending features, including trend arrow indications for monitored parameters and tabular trends reporting. The MR400 stores up to 12 hours of historical trend data, retaining information when new patients are connected to the host and through short power cycles; however, if power is removed for 10 minutes or longer, all stored trend data will be lost. Viewing Tabular Trend Data To view tabular trend data for any available parameter Step Action Press the Trends key. The Tabular Trends menu appears. Allow the trends data to refresh. Select the corresponding button(s) of the parameter(s) that you want to examine. Use the navigation buttons (see page 13‐2) to move through the data pages. Tabular Trends Menu The Tabular Trends menu allows you to control trend functions, to display trended patient data, and to print data when connected to an IP5 and printer. To open the Tabular Trends menu Press the Trends key. Expression MR400 Instructions for Use Trend Data and Printing 13‐1 Notes • Refreshing Trend Data may be displayed while the information on the page is being populated. • In the illustration below, the trend buttons for all parameters are shown in their selected state. 18 17 16 15 14 13 12 11 10 9 8 7 6 Item Name Definition Page Indicates the current page and the total page count of the file Navigation buttons Allows you to move through the listings as follows: Moves one column to the left Moves to the first (oldest) file page Moves up one file page Moves down one file page Moves to the last (most recent) file page Moves one column to the right 13‐2 Trend Data and Printing Expression MR400 Instructions for Use Item Name Definition Parameter headings Identifies the parameter reading for the associated column of data (in the same color as that of the vital sign) Trends key Opens the Tabular Trends menu Agents trend button Displays the AGENT parameter readings, where percentages for primary and secondary end-tidal (Et) and fractional inspired (Fi) gases (ID) are provided in the form: Et ID% Fi ID% N2O trend button Displays the N2O parameter readings O2 trend button Displays the O2 parameter readings TEMP trend button Displays the temperature parameter readings (and the unit of measure) RESP (CO2) trend button Displays the CO2-derived respiration parameter readings (and source) 10 ETCO2 trend button Displays the end-tidal CO2 parameter readings (and the unit of measure) 11 SPO2 trend button Displays the SPO2 parameter readings 12 P2 trend button Displays the P2 parameter readings (and the unit of measure) 13 P1 trend button Displays the P1 parameter readings (and the unit of measure) 14 HR trend button Displays the heart rate parameter readings (and source) 15 NIBP trend button Displays the NIBP parameter readings (and the unit of measure), given in the form: Systolic/Diastolic (Mean) 16 Refresh Trends button Refreshes the readings Note While Refreshing Trend Data, the screen will freeze momentarily; however, audible alarms will continue to function. 17 Tabular Trends menu Is the Tabular Trends menu (see below for details) 18 Date Is the date (and time) of the readings Expression MR400 Instructions for Use Trend Data and Printing 13‐3 The following Tabular Trends menu items are available:. Trend Arrows Arrow Period Data Interval Clear Trends Print Page Print All Stop Print To change settings and control functions in the Tabular Trends menu Step Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. Select from the following menu items: Trend Arrows Arrow Period Data Interval Clear Trends Print Page Print All Stop Print For menu item information, see the appropriate section below. Select from the desired setting of menu options (except Trend Arrows, which is selectable on the Tabular Trends menu.) The setting is entered. To change other settings, repeat steps 2 and 3. Trend Arrows Controls vital sign trend indications, where trend arrows are displayed alongside the VS boxes (except for NIBP and bellows‐derived respiration), with a meaning as defined below. 13‐4 Trend Data and Printing Expression MR400 Instructions for Use WARNING Depending upon the Arrow Period menu option and measurement cycles of the vital signs, NIBP trend arrow indications may not be representative of the current condition of the patient. Trend arrow indications, where is rising is declining is stable is none declared The following options are available: • Off turns off the trend arrows. (Default) • On turns on the trend arrows. Expression MR400 Instructions for Use Trend Data and Printing 13‐5 To control trend arrow indications Step Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. On the Tabular Trends menu, select Trend Arrows. The Trend Arrows menu appears. The current setting is highlighted. Select the desired setting: Off On The setting is changed, and the display is changed accordingly. Arrow Period Controls the time that must elapse before a trend arrow change can occur. The following options are available: • 30 Seconds • 1 Minute • 3 Minutes (Default) • 5 Minutes • 10 Minutes To control the trend arrow period Step Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. On the Tabular Trends menu, select Arrow Period. The Arrow Period menu appears. The current setting is highlighted. 13‐6 Trend Data and Printing Expression MR400 Instructions for Use Step Action Select the desired setting: 30 Seconds 1 Minute 3 Minutes 5 Minutes 10 Minutes The setting is changed. Note If a newly selected period is shorter than the previous period (and the arrows have been on for the longer of the two periods) then immediate recalculation using the new period will occur. However, if the newly selected period is longer than the previous period, recalculation will occur using all available data. Data Interval Controls the time that must elapse before trend data readings are taken. The following options are available: • 1 Minute • 5 Minutes (Default) • 10 Minutes • 15 Minutes • 20 Minutes • 25 Minutes • 30 Minutes • 45 Minutes • 60 Minutes • Auto NIBP (Occurs at the Interval selected for automatic NIBP measurements; see page 12‐15 for details) Expression MR400 Instructions for Use Trend Data and Printing 13‐7 To control the data interval Step Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. On the Tabular Trends menu, select Data Interval. The Data Interval menu appears. The current setting is highlighted. Select the desired setting: 1 Minute 5 Minutes 10 Minutes 15 Minutes 20 Minutes 25 Minutes 30 Minutes 45 Minutes 60 Minutes Auto NIBP The setting is changed. Clear Trends Removes all trend data, useful to ensure that the monitored information reflects data for only one patient. To clear all trend data Step Action Press the Clear Trends key. The Tabular Trends menu appears. Current settings are displayed. On the Tabular Trends menu, select Clear Trends. The Clear Trends menu appears. 13‐8 Trend Data and Printing Follow all associated dialogs to clear the file. The data is erased. Expression MR400 Instructions for Use Print Page Prints the currently displayed Trends page when connected to a printer‐equipped IP5. To print the page Step Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. On the Tabular Trends menu, select Print Page. Print All Prints all Trends pages when connected to a printer‐equipped IP5. To print the all pages Step Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. On the Tabular Trends menu, select Print All. Stop Print Stops printing of the trends page(s) when connected to a printer‐equipped IP5. To stop a current print job Step Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. Expression MR400 Instructions for Use On the Tabular Trends menu, select Stop Print. Trend Data and Printing 13‐9 Printing Functions When equipped with an IP5 and printer, the MR400 can produce hard copies of up to two waveforms, trend information and patient data reports. Notes • If a printer-equipped IP5 is not installed or connected, an indication is displayed on the Print key; see page 13-11. • Any print command from the MR400 automatically initiates a 30-second print cycle at the IP5. • Any print command initiated from the MR400 takes precedence over the IP5 print functions. Printing Parameter-Specific Trends Trended information can be printed separately for every parameter (except bellows‐derived respiration). To print individual trend data Step Action Press the Trends key. The Tabular Trends menu appears. Allow the trends data to refresh. Select the trend button of the parameter that you want to print. The corresponding vital sign data appears. The current page is displayed. Select Print All to print all the data for the parameter, or select Print Page to print the currently displayed data. The data is printed at the IP5. Controlling Printer Outputs To start and stop the printing of a strip chart, press the Print key. If the printer is allowed to run after printing, paper will continue to be output for about 30 seconds before automatically stopping. 13‐10 Trend Data and Printing Expression MR400 Instructions for Use Printer Indications The symbol displayed on the Print key indicates the state of the remote printer, as shown in the table below. Symbol Indication The printer is ready. Printing is in process and seconds remain (25, in the example) until completion. No printer is available. There is a printer error condition. Printer Menu The Printer menu allows you to configure the MR400 for printing when an optional IP5 and printer are connected. To open the Printer menu Press the Setup key and then the Printer key. To open the Printer menu Press the Setup key and then the Printer key. Expression MR400 Instructions for Use Trend Data and Printing 13‐11 . Setup key Printer menu Printer key The following Printer menu items are available: Trace 1 Trace 2 Trace Delay To change settings in the Printer menu Step Action Press the Setup key and then the Printer key. The Printer menu appears. Current settings are displayed. Select from the following menu items: Trace 1 Trace 2 Trace Delay The selected menu appears. Current settings are displayed. (For menu item information, see the appropriate section below.) Select the desired menu item. The current setting is highlighted. 13‐12 Trend Data and Printing Expression MR400 Instructions for Use Step Action Select the desired setting from the menu options. The setting is entered. To change other settings, repeat steps 2, 3 and 4. Trace 1 Prints a selected parameter’s waveform in the Trace 1 waveform location on a strip chart, as shown in the illustration below. (A strip can contain two waveforms.) Note If Trace 2 is off, then Trace 1 is printed using the full 40 mm width of the strip. 11 10 1 Trace 1 setting 2 Date and time (formatted as MM/DD/YY-HH:MM:SS) 3 Patient type 4 Trace delay 5 Trace speed 6 Parameter setting information 7 Values of active parameters at time of printing 8 Trace 2 parameter information 9 Trace 2 setting 10 Trace 2 waveform 11 Trace 1 waveform The following options are available: • ECG 1 outputs the Trace A waveform (Default) Expression MR400 Instructions for Use Trend Data and Printing 13‐13 • ECG 2 outputs the Trace B waveform • SPO2 outputs the Trace C waveform • RESP (CO2) outputs the Trace D waveform • P1 outputs the Trace E waveform • P2 outputs the Trace F waveform To print a waveform in the Trace 1 location Step Action Press the Setup key and then the Printer key. The Printer menu appears. Current settings are displayed. Select Trace 1. The Trace 1 menu appears. The current setting is displayed. Select the desired setting from the menu options: ECG 1 ECG 2 SPO2 RESP (CO2) P1 P2 The setting is entered. Trace 2 Prints a waveform in the Trace 2 location on a strip chart (see example, on page 13‐13). Note When printing two traces, the waveform to grid ratio will not correspond to the displayed waveform/scale indicator size. The following options are available: • Off (Default) • ECG 1 outputs the Trace A waveform. • ECG 2 outputs the Trace B waveform. • SPO2 outputs the Trace C waveform. • P1 outputs the Trace E waveform. 13‐14 Trend Data and Printing Expression MR400 Instructions for Use • P2 outputs the Trace F waveform. • RESP(CO2) outputs the Trace D waveform. To print a waveform in the Trace 2 location Step Action Press the Setup key and then the Printer key. The Printer menu appears. Current settings are displayed. Select Trace 2. The Trace 2 menu appears. The current setting is displayed. Select the desired setting from the menu options: Off ECG 1 ECG 2 SPO2 P1 P2 RESP(CO2) The setting is entered. Trace Delay Allows you to delay the time when sending the trace data to the printer. The following options (in seconds) are available: • 0S • 4 S (Default) • 8S • 16 S To set a printing time delay Step Action Press the Setup key and then the Printer key. The Printer menu appears. Current settings are displayed. Select Trace Delay. The Trace Delay menu appears. The current setting is displayed. Expression MR400 Instructions for Use Trend Data and Printing 13‐15 Step Action Select the desired setting from the menu options: 0S 4S 8S 16 S The setting is entered. 13‐16 Trend Data and Printing Expression MR400 Instructions for Use CHAPTER 14 Maintenance and Troubleshooting WARNINGS • Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. • To reduce the possibility of damage to the equipment or injury to patients/personnel, perform all cleaning, disinfection, maintenance, software update, testing, disassembly and repair outside of the MR system room. • Contact: If you discover a problem with any of the equipment, contact technical support or authorized service personnel. General Cleaning Guidelines Keep the MR400 and accessories free of dust, dirt and pathogens. After cleaning and disinfection, always check the equipment carefully. Stop using equipment that shows signs of deterioration or damage. Observe the following general precautions when cleaning: • Always dilute the cleaning substance according to the manufacturer’s instructions or use lowest possible concentration. • Never allow liquid to enter the equipment. • Never immerse any part of the equipment in liquid. • Never pour liquid onto the equipment. • Never use abrasive material to wipe the equipment. Note For answers to questions regarding infection control, call us at (877) 468-4861 (inside the USA) or +31 (0) 499 378299 (outside the USA). Clean using a lint‐free cloth, moistened with warm water (40°C / 104°F maximum) and mild soap, a diluted non‐caustic detergent or alcohol‐based cleaning agent. Never use strong solvents such as acetone or trichloroethylene. Stains can be removed by scrubbing briskly with a moistened cloth. If disinfection is required, clean the equipment before disinfecting it. When cleaning the touch screen, wipe it gently using a soft non‐woven cloth with 80% diluted alcohol mixture. Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐1 Use only the Royal Philips‐approved substances and methods listed in this chapter to clean or disinfect the equipment. Royal Philips makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Warranty does not cover damage caused by using unapproved substances or methods. The recommended types of disinfecting agents are listed in the table below. We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Consult your facility's Infection Control Officer or Epidemiologist. For comprehensive details on cleaning agents and their efficacy refer to Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health Care and Public‐Safety Workers issued by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, February 1989. Also refer to any policies that apply within your facility and country. Product Name Product Type Cavicide Disinfectant: CaviWipes® Towelette Coverage Disinfectant: Coverage® Spray TB, TB Plus, HB Plus* Spray Sani-Cloth Germicidal Wipes* Towelette Sklar Disinfectant* Towelette, spray *Any product residue should be removed by wiping the surface. Removing all Power to the MR400 In order to clean, disinfect, inspect, test or service the MR400, it may be necessary to remove power to the cart. To remove all power to the MR400 cart Step 14‐2 Maintenance and Troubleshooting Action Press then hold the power switch for approximately 2 seconds to turn off power to the cart. Pull the plug of power cord from the AC wall outlet. Then, lift the strain relief and remove the power cord from the AC receptacle on the cart. Disconnect any gating connection from the cart; otherwise, remove the shield cap. Expression MR400 Instructions for Use Step Action Press the battery eject button to partially eject a main cart battery from a battery compartment, and then grasp the battery and pull to remove it completely from the MR400. Battery compartment Battery eject button Main cart battery (If the battery does not release, apply a slight forward pressure to the battery while pressing the battery eject button.) Repeat steps 1 and 2 to remove the other main cart battery on the opposite side of the MR400. Remove the two screws that secure the service panel cover to the MR400 and then remove the service panel cover. Screws Expression MR400 Instructions for Use Service panel cover Maintenance and Troubleshooting 14‐3 Step Action Locate the battery switch and toggle it into the Off (O) position. Battery switch Restoring all Power to the MR400 To restore all power to the MR400, see page 1‐16. Removing Power from the Wireless Modules In order to clean, disinfect or inspect a wireless module it may be necessary to remove power from the device. To turn power off to the wireless modules, proceed according to the module type: • wECG module: Remove all installed batteries (see page 1‐25). • wSpO2 module: Remove the battery (see page 1‐27). Restoring Power to the Wireless Modules To restore all power to the wireless modules, proceed according to the module type: • wECG module: Install at least one battery (see page 1‐24). • wSpO2 module: Install one battery (see page 1‐26). User Routine-Checks and Planned Maintenance This product requires routine checking, planned maintenance and testing that must performed on a scheduled basis to keep the product operating safely, effectively and reliably. User Routine‐Checks Program 14‐4 Maintenance and Troubleshooting Expression MR400 Instructions for Use The user of the product must institute a routine‐checks program as detailed in the table below. The user of the product shall make sure that all checks and actions have been satisfactorily completed before using the product for its intended purpose. Area / Item Frequency Required Action Accessories Daily Clean and inspect for damage; see page 14-7. Alarms Daily Confirm proper function; see Testing Alarms on page 14-11. Module batteries Every 8 hours of use Recharge; see page 2-16 for displayed indications, and refer to the battery charger’s IFU for recharging instructions. Wireless module If dropped Inspect and clean (see page 14-9) then test (see page 14-12). Planned Testing Program Planned maintenance may only be carried out by qualified and authorized personnel, and is comprehensively described in the service documentation. Philips provides a full planned maintenance and repair service on both a call basis and a contract basis. Full details are available from your Philips Service Organization. A summary of service events and maintenance requirements appears in the table below. Area / Item Frequency Required Action Monitor cleaning Every 6 months Perform external cleaning System AGENT option Once per year or as specified by local laws Perform calibration. System - CO2 (LoFlo option) Once per year or as specified by local laws Perform calibration. System- NIBP Once per year or as specified by local laws Perform calibration. System Once per year or as specified by local laws, or after any type of repair or service event Perform Visual Inspection, and Power On, Verification and Safety Tests Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐5 Area / Item Frequency Required Action Cart batteries: two main and two reserve Every 12 months • Replace the main batteries; see page 1-16. Module batteries Every 12 months Replace the module batteries; see page 1-23. • Replace the reserve batteries; contact technical support. Cleaning, Disinfection, and Damage Inspection Cleaning and disinfection of this product is required periodically. General guidelines for each are given below. WARNING Always isolate the product from the mains electrical supply and remove and disconnect batteries before cleaning, disinfecting or sterilizing to prevent electric shocks. CAUTION Never allow water or other liquids to enter the product, since these may cause electrical shortcircuits or metal corrosion. Cleaning and disinfection techniques for both the product and the room must comply with all applicable local laws and regulations. Cleaning Enameled parts and aluminum surfaces should only be wiped clean with a damp cloth and a mild detergent, and then rubbed down with a dry woolen cloth. Never use corrosive cleaning agents, solvents, abrasive detergents or abrasive polishes. If you are not sure about the properties of a cleaning agent, do not use it. Disinfection Those parts of the product that are suitable for such treatment, including accessories and connecting cables, can be disinfected by gently wiping the surfaces with a cloth dampened with a suitable agent for a brief period (30 seconds to 1 minute) or as directed by the substance manufacturer. Never use corrosive or solvent disinfectants or sterilizing agents. If you are not sure about the properties of a disinfectant or sterilizing agent, do not use it. 14‐6 Maintenance and Troubleshooting Expression MR400 Instructions for Use WARNING Do not use flammable or potentially explosive disinfecting sprays. Such sprays create vapors, which can ignite, causing fatal or other serious personal injury. CAUTION Disinfecting a medical product room by means of sprays is not recommended, since the vapor could penetrate the product, causing electrical short-circuits, metal corrosion or other damage to the product. Cleaning, Disinfecting, and Inspecting the Accessories Any reusable patient accessory (such as ECG cables, SPO2 attachments and probes, temperature sensors, et cetera) must be cleaned and disinfected before initial use and after each use to protect patients and personnel from a variety of pathogens. Use soap and water, and a suggested disinfectant and method, to clean and disinfect the accessories. The warranty does not cover damage caused by unapproved substances or methods. During the cleaning process, inspect the accessory for damage. The accessories are exposed to potentially damaging situations during use and cleaning. Before each use, carefully inspect the accessories for the following signs of damage: • Cracks, holes, tears, gouges, cuts, et cetera. • Cracks or other signs of damage to the connector, including bent or damaged pins. • Disposable accessories must be discarded and replaced with new items. WARNING Cracks, tears, cuts and gouges interfere with standard cleaning procedures and therefore pose a potential risk to patients and personnel. If you see any sign of damage to any accessory, immediately discontinue use. WARNING Single-use devices, as indicated on the device packaging, should be disposed of after use and must never be reused. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. CAUTIONS • Never immerse an accessory in any cleaning fluid. • Do not autoclave any part of the equipment. Disinfect the accessory as determined by your facility’s policy. Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐7 To clean a reusable accessory Step Action Remove the accessory from use. Remove all visible debris from the accessory using soap and water. CAUTION Never pour liquid onto the accessory. Clean the accessory by thoroughly wiping it using CaviWipes disinfectant towelettes. Discard the used towelettes (refer to your facility's biohazard procedure for disposal). Note Follow the Instructions for Use from the disinfectant manufacturer to clean the probe. Disinfect the accessory by thoroughly wetting it using CaviWipes disinfectant towelettes. Discard the used towelettes (refer to your facility's biohazard procedure for disposal). Note Follow the Instructions for Use from the disinfectant manufacturer to disinfect the probe. Allow the accessory to dry. (No rinsing is required.) Check the accessory for any residual debris. If any debris is present, repeat steps 2 through 5 then re‐examine the item before proceeding. Note 14‐8 Maintenance and Troubleshooting Disposable SPO2 attachments: After some use, adhesive residue may accumulate at the fiber heads on the probe. Carefully remove any residue with alcohol to keep the glass fiber ends clean. Check the accessory for damage (cracks, holes, tears, cuts, et cetera) and discard the accessory if damage is found. Store the accessory; see page 2‐12 for details. Expression MR400 Instructions for Use Cleaning, Disinfecting, and Inspecting MR400 and Wireless Modules Follow the general guidelines to clean the MR400 cart and the wECG and wSpO2 modules. Always turn off the cart and the wireless modules to perform cleaning. Never immerse any portion of the cart or wireless modules in fluid or attempt to clean the devices by directly applying liquid cleaning agents. During the cleaning process, inspect the MR400 and the wireless modules for damaged, loose or missing hardware; if found, take corrective action or contact technical support. WARNING Always disconnect the MR400 from AC mains power, and remove the batteries from the cart and the wireless modules, before performing any cleaning or maintenance. To avoid an electrical hazard, never immerse any part of the MR400 in any cleaning agent or attempt to clean it with liquid cleaning agents. CAUTIONS • Other than those specified in the preceding table, avoid ammonia-, phenol- and acetonebased cleaners as they will damage the surfaces of the MR400. • Disinfect the MR400 cart and wireless modules as determined by your hospital’s policy to avoid long term damage to the product. • Do not permit liquid to contact the front or rear of the display panel. Do not permit liquid to drip into or around the touch screen. Contact technical support if liquid enters any component. • If the MR400 becomes accidentally wet during use, discontinue operation until all affected components have been cleaned and permitted to completely dry. Contact technical support if additional information is required. To clean and disinfect the cart and wireless modules Step Action Turn off the MR400 and disconnect all power; see page 14‐2. Remove the battery from each wireless module; see page 14‐4. Clean the touch screen by wiping it gently using a soft non‐woven cloth with 80% diluted alcohol mixture. Remove all visible debris from the cart and wireless modules using soap and water. CAUTIONS Never pour liquid onto the equipment. Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐9 Step Action Clean the cart and modules by thoroughly wiping the devices using CaviWipes disinfectant towelettes. Discard the used towelettes (refer to your facility's biohazard procedure for disposal). Note Follow the Instructions for Use from the disinfectant manufacturer to clean the cart and wireless modules. Disinfect the cart and modules by thoroughly wetting the devices using CaviWipes disinfectant towelettes. Discard the used towelettes (refer to your facility's biohazard procedure for disposal). Note Follow the Instructions for Use from the disinfectant manufacturer to disinfect the cart and wireless modules. Allow the cart and the wireless modules to dry. (No rinsing is required.) Check the cart and the wireless modules for any residual debris. If any debris is present, repeat steps 3 through 6 then re‐examine the cart and wireless modules before proceeding. Check the cart and wireless modules for damaged, loose or missing hardware. Contact technical support if necessary. 10 Store the module; see page 2‐12 for details. Sterilization The MR400 cart, wireless modules and accessories are not sterilizable; do not immerse any part of these items in fluid or attempt to clean them with unspecified liquid cleaning agents. Severe damage, not covered by the warranty, will result. 14‐10 Maintenance and Troubleshooting Expression MR400 Instructions for Use Testing Alarms Note If a problem with the alarm sound or messaging system is suspected, discontinue use of the MR400 and immediately refer it to authorized service personnel for evaluation. To verify the alarm functions Step Action With the MR400 turned on and not in suspend mode, ensure that Alarm Sound is turned on in the Alarms menu. Make sure that the lower alarm limit for SPO2 is not off. Check the battery indicator on the wSpO2 module to ensure that enough charge exists: • Green battery indicator = Charge sufficient; proceed to step 5. • Red battery indicator = Charge low; proceed to step 4. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Insert a charged module battery into the wSpO2 module and then recheck the battery indicator to ensure a sufficient charge before proceeding; see page 1‐26. Check the network channel indicator on the wSpO2 module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 7. • Flashing = No communication; proceed to step 6. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Expression MR400 Instructions for Use Ensure that the wSpO2 module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. Place the SPO2 attachment on your finger and wait for a value to appear in the SPO2 VS box. Maintenance and Troubleshooting 14‐11 Step Action Remove your finger from the attachment. Verify the following: • Non‐Pulsat or Probe Off appears in the SPO2 alarm flag area, • The SPO2 waveform flat lines. • The numeric flashes in yellow; and, • The alarm tone sounds. This completes the test of the alarm system. Testing a Dropped Wireless Module In the event that the wECG or wSpO2 module has been dropped, it is important to determine the functionality of the device before attempting to monitor a patient. To verify the basic functions of a dropped wireless module Step 14‐12 Maintenance and Troubleshooting Action Perform a visual examination the dropped module for signs of breakage (cracked housings, damaged connectors, et cetera): • If no signs of damage are present, go to step 2; or, • If noticeable damage is present, go to step 6. Ensure that a fresh module battery is installed. (If checking the wECG module, ensure that two fresh batteries are installed.) Then, check the module and proceed accordingly: • If the battery indicator(s) and network channel indicator are illuminated, go to step 3; or, • If the battery indicator(s) and network channel indicator are NOT illuminated, go to step 6. Ensure that the module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. Check the status information pane (see page 2‐16) on the MR400 and proceed accordingly: • If the battery time‐remaining indication and communication status are present for the dropped module, go to step 5; or, • If a red X is present (or if blank) for the dropped module, go to step 6. Expression MR400 Instructions for Use Step Action This completes basic functional testing of the dropped module. However, if during further usage, problems are encountered, such as status messages (Lead Fail, No Probe, et cetera) then discontinue use of the module and replace it before using the MR400 system. Discontinue use of the module and replace it before using the MR400 system. Verification Testing Verification testing for the MR400 can in some cases be performed by the user, provided the necessary accessories and test equipment are available. However, many verification tests require specialized equipment and training, and as a result must be performed by qualified service personnel; refer to the service manual (REF 989803181911) for a comprehensive testing procedure and contact technical support with any questions. Anesthetic Oxygen (O2) Sensor Depletion The anesthetic oxygen (O2) sensor uses galvanic technology and has a limited shelf life, as indicated by the expiration date printed on the packaging and sensor. Take note this expiration date and plan accordingly for replacement scheduling of the O2 sensor; see page 14‐13 for instructions. If the O2 sensor is missing or malfunctioning, Agent HW Fail ‐ O2 Sensor will be displayed shortly after activation of the AGENT parameter; or, during CO2 use, Turn Off CO2, Replace O2 Sensor will be displayed. In each case, the O2 sensor must be replaced before Agent and gas monitoring can proceed. Replacing the O2 Sensor The O2 sensor is located behind the service panel cover at the back of the WPU. WARNING The gas sampling line must not be connected to the patient airway adapter or any other gas source during oxygen sensor replacement, as it will cause an incorrect calibration of the O2 reading. Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐13 To replace the O2 sensor. Step Action Turn off the MR400. Ensure that any gas sampling line has been disconnected from the water trap on the patient connection panel. Remove the two screws that secure the service panel cover to the back of the WPU and then remove the service panel cover. Screws Service panel cover Locate the sensor tool and the O2 sensor port. O2 sensor O2 tool Place the sensor tool into the slot in the O2 sensor, then turn the sensor counterclockwise until it disengages from the sensor port. Slot 14‐14 Maintenance and Troubleshooting Expression MR400 Instructions for Use Step Action Insert a new O2 sensor into the sensor port and then, using the sensor tool, turn the sensor clockwise until secure. Sensor port O2 sensor Replace the service panel cover and secure it using the two screws. Connect a gas sampling line to the water trap. Turn on the MR400. 10 Turn on the Agents parameter and allow the system to run until CO2 Warming Up is no longer displayed. 11 Calibrate the O2 sensor by performing the following steps: a. Press the Monitor key. b. On the Monitor Setup menu, select Service(Bio‐Med). c. On the Service(Bio‐Med) menu, select Gas Cal. d. On the Gas Cal menu, select O2 Cal. e. When prompted: Flow Room Air for 10 Seconds, Do you wish to continue? Select Yes to proceed. Readjusting CO2 Zero will be displayed until calibration is complete. Updating Software As revisions to the software become available, the MR400 can be updated; refer to the service manual (REF 989803181911). It is recommended that you backup your settings prior to updating software, so that they can be restored afterward; see Edit User Settings on page 3‐15. Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐15 WARNING When performing software updates (or upgrades) to the operating software of the MR400, ensure that all remaining devices in the monitor’s network are at the same or a compatible software revision level. Failure to observe this requirement could result in compatibility conflicts, communication problems, et cetera. Calibrating the Touch Screen Note Touch screen calibration is not routinely required, but will occur after installation of new operating software. To calibrate the touch screen menu, refer to the service manual (REF 989803181911). Troubleshooting Methods for troubleshooting problems when the equipment seems to be functioning incorrectly include using displayed alarm messages as a starting point; see chapter 4 for a listing. Planned maintenance and user routine‐testing are also helpful ways to confirm device operations or to help identify a problem; see page 14‐4. Troubleshooting the MR400 is comprehensively described in the service documentation. Philips provides a full planned maintenance and repair service on both a call basis and a contract basis. Full details are available from your Philips Service Organization. Repair The MR400 contains no user‐serviceable parts. All repairs must be performed by trained service personnel. All repairs on products under warranty must be performed by authorized personnel or in an authorized Service and Repair Center. Unauthorized repairs will void the warranty. Circuit diagrams, component part lists, descriptions, calibration instructions, and other information to assist service personnel in the repair of the serviceable parts of the device are available in the service manual (REF 989803181911) and on request. 14‐16 Maintenance and Troubleshooting Expression MR400 Instructions for Use WARNINGS • A shock hazard exists if the MR400 is operated without covers. • Do not modify the MR400 Patient Monitoring System without authorization of the Invivo (Royal Philips). If the MR400 fails to function properly or requires maintenance, contact technical support: 1‐877‐INVIVO1 or 1‐877‐468‐4861 Internationally, please contact your Key Market representative. For a current listing, go to www.invivocorp.com CAUTIONS • This product, or any of its parts, must not be repaired other than in accordance with written instructions provided by Invivo (Royal Philips), or altered without prior written approval. • No repair should ever be undertaken or attempted by anyone not having a thorough knowledge of the repair of Invivo (Royal Philips) patient monitoring systems. Only replace damaged parts with components manufactured or sold by Invivo (Royal Philips). Contact the Technical Service and Repair Center for assistance and service. • The user of this product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Invivo (Royal Philips) or its authorized service personnel. Environmental Requirements Philips Medical Systems is concerned to help protect the natural environment, and to help ensure continued safe and effective use of this product, through proper support, maintenance and training. Therefore Philips products are designed and manufactured to comply with relevant guidelines for environmental protection. As long as the product is properly operated and maintained, it presents no environmental risks. However, the product may contain material(s), which could be harmful to the environment if disposed of incorrectly. Use of such material(s) is essential to performing the functions of the product, and to meeting statutory and other requirements. This section of the Instructions for Use is directed mainly at the user / owner of the product. Operators are not usually involved in disposal, except in the case of certain batteries; see page 14‐22 for those details. Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐17 Passing the Product on to another User If this product passes to another user, it must be in its complete state, including all product support documentation. Make the new user aware of the support services that Philips Medical Systems provides for installing, commissioning and maintaining the product. Before passing on the product or taking it out of service, all patient data must be (backed up elsewhere if necessary, and) unrecoverable be deleted on the product. It must be remembered by all existing users that passing on medical electrical products to new users may create serious technical, medical and legal (e.g. on privacy) risks. Such risks can arise even if the product is given away. Existing users are strongly advised to seek advice from their local Philips Medical Systems representative before committing themselves to passing on any product. Alternatively, contact the manufacturer. Once the product has been passed on to a new user, a previous user may still receive important safety‐related information, such as bulletins and field change orders. In many jurisdictions, there is a clear duty on the previous user to communicate such safety‐related information to new users. Previous users who are not able or prepared to do this should inform Philips Medical Systems about the new user, so that PMS can provide the new user with safety‐related information. Packaging the MR400 To package the MR400 for shipment, use the MR400 packing materials to safely transport the monitor. Remove all accessories before packaging. CAUTION If shipment of the MR400 is required, batteries must be removed prior to transport and internal batteries must be disconnected. To pack the MR400 Step 14‐18 Maintenance and Troubleshooting Action In a location outside of the MR magnet room, ensure that the AC mains power is disconnected. Ensure that both main batteries have been removed and that the battery switch for the reserve batteries is off; see page 14‐2. Expression MR400 Instructions for Use Step Action Cover the display panel and the WPU with protective film then install foam A over the display panel. With the packaging oriented so that the slotted foam will be nearest the top, raise the crate into an upright position. Roll the MR400 into the crate and then carefully lower the crate. Slotted foam Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐19 Step 14‐20 Maintenance and Troubleshooting Action Ensure that the guide handle is located in the slotted foam (see step 4)—if necessary, push the MR400 from the bottom. Pack the MR400 accessories in the accessory box (B) and then place the accessory box into the crate, alongside the display panel as shown below. Insert foam C over the WPU and between the base of the MR400 and the crate. Place the lid on the crate. Expression MR400 Instructions for Use Step Action Install all the clips into the lid on the crate, ensuring that each is locked and that the crate is secure. Final Disposal of the Product Final disposal is when the user disposes of the product in such a way that it can no longer be used for its intended purposes. WARNING Do not dispose of this product (or any parts of it) in industrial or domestic waste. The product may contain materials and hazardous substances that can cause serious environmental pollution. The system also contains privacy sensitive information. It is advisable to contact your Royal Philips Service Organization before disposing of this product. Philips Healthcare supports users in: • Recovering reusable parts. • Recycling of useful materials by competent disposal companies. • Safe and effective disposal of equipment. For advice and information, contact your Philips Service Organization first, or otherwise the manufacturer. Disposal of the MR400 and Accessories The MR400 cart, wireless modules and accessories are subject to strict disposal regulations for user and environmental safety. Never dispose of waste electrical and electronic equipment as Expression MR400 Instructions for Use Maintenance and Troubleshooting 14‐21 unsorted municipal waste. Collect it separately so that it can be safely and properly reused, treated, recycled or recovered. WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the MR400 appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. Do not dispose of this product (or any parts of it) in industrial or domestic waste. The system may contain materials such as lead, tungsten or oil, or other hazardous substances that can cause serious environmental pollution. The system also contains privacy sensitive information. It is advisable to contact your Royal Philips Service Organization before disposing of this product. You can disassemble the MR400 and accessories as described in the service manual. Fitting, Removing and Disposing of Batteries REACH requires Philips Healthcare (PH) to provide chemical content information for Substances of Very High Concern (SVHC) if they are present above 0.1% of the product weight. Components within electric and electronic equipment may contain phthalates above the threshold (e.g., bis 2‐ ethyl [hexyl] phthalate, CAS nr.: 117‐81‐7). The SVHC list is updated on a regular basis. Therefore, refer to the following Philips REACH website for the most up‐to‐date list of products containing SVHC above the threshold: http://www.philips.com/about/sustainability/reach.page The lithium batteries found in the system and some of the accessories or optional equipment may be subject to strict disposal regulations for user and environmental safety. Observe and adhere to your current local regulations when disposing of batteries. CAUTIONS • Never heat or throw a battery into fire. Heating the battery will damage the safety circuitry, which can cause rupture or ignition of the battery. • Never disassemble a battery. The batteries contain hazardous material that must be recycled or disposed of properly. (Refer to the disposal guidelines above.) 14‐22 Maintenance and Troubleshooting Expression MR400 Instructions for Use APPENDIX A Specifications General Patient Safety Conforms to ANSI/AAMI ES 60601‐1. Certified to CAN/CSA C22.2 No. 60601‐1‐08; IEC 60601‐1‐2 Conforms to 93/42/EEC as amended by 2007/47/EEC, Medical Device Directive Defibrillator protection up to 5 KVDC According to the degree of ingress protection: Rated IP21 (Protected against access to hazardous parts and the ingress of solid foreign objects greater than 12.5mm (0.5 inch), and against vertically dripping liquid.) Where appropriate, the equipment complies with worldwide standards for safety and performance of each system feature, when considering the indications for use within the MR environment. This equipment complies with the following international industry standards for safety and performance: • ISO 14971, Medical devices ‐ Application of risk management to medical devices • IEC 60601‐1, Medical Electrical Equipment Part 1: General Requirements for Safety (Amendment 1) IEC 60601‐ 1, clause 16, Medical Electrical (ME) Systems • ETSI EN 300‐440‐1, Electromagnetic compatibility and Radio spectrum Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range • ETSI EN 300‐440‐2, Electromagnetic compatibility and Radio spectrum Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range • ETSI EN 301‐489‐1, Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements‐V1.5.1 • ETSI EN 301‐489‐3, Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Electromagnetic Compatibility (EMC) Standard for Radio Equipment and Services; Part 3: Specific Conditions for Short‐Range Devices (SRD) Operating on Frequencies between 9 KHz and 40 GHz‐ V1.4.1 • EN 980: Symbols for use in labeling of medical devices • EN 1041: Information supplied by the manufacturer of medical devices • BS EN 12470‐4: 2001+A1:2009, Clinical Thermometers – Part 4: Performance of Electrical Thermometers for Continuous Measurement • IEC 60068‐2‐1, Environmental Testing – Part 2‐1: Test–Test A: Cold • IEC 60068‐2‐2, Environmental Testing – Part 2‐2: Test–Test B: Dry Heat • IEC 60068‐2‐6, Environmental Testing – Part 2: Tests–Test FE: Vibration (Sinusoidal) • IEC 60068‐2‐27, Environmental Testing – Part 2: Tests–Test EB and Guidance: Bump • IEC 60068‐2‐64, Environmental Testing – Part 2: Test Methods Test FH: Vibration Broad‐band Random (Digital Control) and Guidance • IEC 60601‐1‐2, Medical Electrical Equipment Part 1‐2: General Requirements for Safety ‐ Collateral Standard: Electromagnetic Compatibility ‐ Requirements and Tests Expression MR400 Instructions for Use Specifications A‐1 General • IEC 60068‐2‐64, Environmental Testing – Part 2: Test Methods Test FH: Vibration Broad‐band Random (Digital Control) and Guidance • IEC 60601‐1‐2, Medical Electrical Equipment Part 1‐2: General Requirements for Safety ‐ Collateral Standard: Electromagnetic Compatibility ‐ Requirements and Tests • IEC 60601‐1‐6, Medical Electrical Equipment ‐ Part 1‐6: General Requirements for Safety ‐ Collateral Standard: Usability • IEC 60601‐1‐8, Medical Electrical Equipment – Part 1‐8: General Requirements for Basic Safety and Essential Performance – Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems • IEC 60601‐2‐27, Particular Requirements for Safety ‐ Specification for Electrocardiographic Monitoring Equipment • IEC 60601‐2‐33, Particular requirements for the safety of magnetic resonance equipment for medical diagnosis • IEC 60601‐2‐34, Medical Electrical Equipment – Part 2‐34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment • IEC 60601‐2‐49, Medical Electrical Equipment ‐ Part 2‐49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment • IEC 80601‐2‐30, Medical Electrical Equipment ‐ Part 2‐30: Particular Requirements for the Safety, Including Essential Performance, of Automatic Cycling Non‐Invasive Blood Pressure Monitoring Equipment • ISO 80601‐2‐61, Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use • ISO 80601‐2‐55, Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors and Part 2‐55 • Dangerous Goods Regulations 2008, Dangerous Goods Regulations 2008 – UN ID 3090 • UN DOT T1‐T8, UN Transport Testing for Secondary Lithium Cells • ISTA Procedure 1A, Fixed Displacement Vibration and Shock Testing for Packaged Products weighing 150 lb (68 kg) or less • Directive 2011/65/EU, Restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS2) • ISO 10993‐1, Biological Evaluation of Medical Devices ‐ Part 1: Evaluation and Testing • ISO 10993‐5, Biological Evaluation of Medical Devices ‐ Part 5: Tests for Cytotoxicity: In vitro methods • ISO 10993‐10, Biological Evaluation of Medical Devices ‐ Part 10: Tests for Irritation and Delayed‐Type Hypersensitivity • 21 CFR Part 801, Code of Federal Regulations – Medical Devices: Labeling • 49 CFR Part 173.185, Code of Federal Regulations – Transportation – Other Regulations Relating to Transportation – Pipeline and Hazardous Materials Safety Administration, Department of Transportation – Hazardous Materials Regulations – Shippers‐General Requirements for Shipments and Packagings – Non‐bulk packaging for hazardous materials other than class 1 and class 7 – Lithium cells and batteries • 1999/5/EC, R&TTE Directive (Radio and Telecommunications Terminal Equipment) A‐2 Specifications Expression MR400 Instructions for Use General • 2002/96/EC, Directive on Waste of Electrical and Electronic Equipment • 2006/66/EC, Battery Directive • ANSI/AAMI BP22, Blood Pressure Transducers • ANSI/AAMI EC13, Cardiac Monitors, Heart Rate Meters, and Alarms • ANSI / AAMI EC53, ECG trunk cables and patient leadwires • ASTM E‐1112—2000, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature • ASTM F2052‐14, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Device in MR Environment • ASTM F2503‐13, Standard Practice for Marking Medical Devices and other Items for Safety in the MR Environment • FCC Part 15.249 (47 CFR Part 15.249), Radio Frequency Devices – Operation within the bands 902‐928 MHz, 2400‐2483 MHz, 5725‐5875 MHz, and 24.0‐24.25 GHz • UL 2054, Standard for Household and Commercial Batteries • IEC 62133, Secondary cells and batteries containing alkaline or other non‐acid electrolytes, Standard for Household and Commercial Batteries • RSS‐210, Issue 7, Low‐power License‐exempt Radio Communication Devices (All Frequency Bands): Category 1 Equipment • SAA AS/NZS 3200.1.2, Medical Electrical Equipment Part 1‐2: General Requirements for Safety ‐ Collateral Standard: Electromagnetic Compatibility ‐ Requirements and Tests • ISO 14155‐1, Clinical investigation of medical devices for human subjects. Part 1: General requirements • IEC 62304, Medical Device Software: Software life cycle processes • JIS T 0601‐2‐34, Medical Electrical Equipment – Part 2‐34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment • JIS T 1306, Continuous Measuring Clinical Electrical Thermometers • ISO 80601‐2‐56, Medical electrical equipment. Part 2‐56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Power Requirements, Cart Operating Voltage Range 100 to 240 VAC, ± 10 percent Frequency Range 50 to 60 Hz, single phase Current 1.4 A @ 100 VAC / 0.7 A @ 240 VAC Power Consumption, Maximum 65 Watts Protection Internally fused (3.15 A, slow blow @ 250 VAC), AC line and neutral Expression MR400 Instructions for Use Specifications A‐3 General Battery Type Cart: Lithium‐Ion Module: Lithium polymer Operation Time (Fully charged) Cart: Dependent upon enabled parameters and settings: • All displays, alarms, and monitoring functions continuously for 8 hours • ECG & SPO2 continuously for 8 hours • CO2 continuously for 6 hours (with or without AGENT) • P1 and P2 continuously for 6 hours • AGENT analysis continuously for 6 hours • Temperature continuously for 6 hours • NIBP readings every 5 minutes for 6 hours Module: Approximately 8 hours Charge Time Cart: To recharge a fully discharged battery is approximately 12 hours with the MR400 turned off. Battery charge time to 90 percent of capacity is approximately 6 hours. Module: To recharge a fully discharged battery is approximately 4 hours. Battery charge time to 90 percent of capacity is less than 4 hours. Minimum Voltage (For normal operation) Cart: 14.4 V Module: 3.7 V Capacity Cart: 75 Wh Module: 3.1 Wh Environment Operating Temperature Range 10 to 35°C (50 to 95°F) Storage and Transport Temperature Range Batteries: 0 to 40°C (32 to 104°F) Cart: ‐20 to 60°C (‐4 to 140°F) Wireless modules and all other accessories not specified below: ‐20 to 60°C (‐4 to 140°F) ECG skin prep gel: Follow instructions on tube Quadtrodes: 10 to 32°C (50 to 90°F) Transducer and cable (optional) (REF 989803179721): ‐15 to 60°C (‐50 to 140°F) O2 sensor (AGENT option), Storage Temperature: +5 to 25 °C (+41 to 77 °F); Transport Temperature ‐40 to 50 °C (‐40 to 122 °F) (When storing or transporting in temperatures beyond the ranges specified above, remove the designated component and store or move it appropriately.) A‐4 Specifications Expression MR400 Instructions for Use General Relative Humidity Range 5 to 80 percent, non‐condensing Philips IBP Transducer and cable (optional): 15 to 80 percent, non‐ condensing Operating Pressure Range Up to 3,000 m (9,842 ft) above sea level (708 mbar or 531 mmHg) Storage and Transport Pressure Range 708 mbar (708 hPA or 531 mmHg) to 1020 mbar (1020 hPA or 765 mmHg) MRI System Range 0.7 to 3.0 Tesla, at RF power levels not exceeding 4W/kg SAR, and 7.2 µT B1rms in all orientations Dimensions and Weights (All measurements made with batteries but without accessories; fully loaded cart weight also provided) Height Cart: 127.3 cm (50.1 inches) Wireless ECG patient module: 18.2 cm (7.17 inches) Wireless SpO2 patient module: 13.0 cm (5.13 inches) Width Cart: 47.5 cm (18.7 inches) Wireless ECG patient module: 6.7 cm (2.65 inches) Wireless SpO2 patient module: 6.5 cm (2.55 inches) Depth Cart: 55.9 cm (22 inches) Wireless ECG patient module: 3.1 cm (1.24 inches) Wireless SpO2 patient module: 3.1 cm (1.24 inches) Weight Cart: 46.9 kg (103.3 pounds); fully loaded: 50.2 kg (110.7 pounds) Wireless ECG patient module: 340 g (12 ounces) Wireless SpO2 patient module: 204 g (7.2 ounces) Display Type Liquid Crystal Display (LCD), touch screen, color Drive System a‐Si TFT active matrix Screen Size 39.5 cm (15.6 inches) diagonal Aspect Ratio 16:9 Area 344.2 (H) by 193.5 (V) mm Pixels 1366 (H) by 768 (V) pixels Dot Pitch 0.084 (H) by 0.252 (V) mm Pixel Pitch 0.252 (H) by 0.252 (V) mm Contrast Ratio 500:1 (typical) Backlight LED Polarizer Surface Anti‐glare Tilt Adjustable, 5° to 35° Expression MR400 Instructions for Use Specifications A‐5 General Sweep Speed For ECG, SPO2, and IBP, a speed of 25 mm/second gives 9.1 seconds of display time, while 50 mm/second gives 4.6 seconds. For respiration, a speed of 3.125, 6.25, 12.5 or 25 mm/second is provided. Waveform Display Mode Fixed trace, moving erase bar Waveform Display Height (ECG, Single Trace) ≥ 40 mm Waveform Display Height (ECG, Dual Trace) ≥ 20 mm Waveform Display Height (SPO2, CO2, P1, P2) ≥ 25 mm Waveform Display Length ≥ 228 mm Battery Indication Time remaining, red low warning Alarm Light, Priority Indication High: Red, flashing, 1.5 Hz with a 50% duty cycle Medium: Yellow, flashing, 0.75 Hz with a 50% duty cycle INOP: Blue, steady Alarm Visibility Legible at 1 meter (assuming a visual acuity of 20/20 and with no line of sight obstructions) Alarm Sound Volume At the maximum setting (10): 86 dB Alarm Sound, Priority Indication Three tones of fixed pitch mnemonic notes: High: c c c – c c Medium: c c c INOP: e c Communication Attenuation 110 dB conducted Displayed Information Time Battery‐backed quartz crystal clock Alarms High and low limits selectable for patient parameters Note No algorithms were used to determine the manufacturer configured alarm presets. ECG A‐6 Specifications ECG waveform scale, displayed leads (2) Expression MR400 Instructions for Use Displayed Information Heart Rate Automatic mode selects the vital sign to provide the heart rate according to vital sign source availability and priority. If no source available (if no vital sign meets the criteria, then the heart rate source will be displayed as None and no heart rate will be produced. Manual mode selection to provide the heart rate is also available. Pulse Oximeter Pulse rate, pulse waveform (normalized) and percent saturation Trends Heart rate, respiration rate, P1 and/or P2(systolic, diastolic, mean), NIBP (systolic, diastolic, mean), EtCO2, O2, N2O, SpO2, and Agents CO2 Both end‐tidal and fractional inspired CO2 NIBP Pressures (systolic, mean, diastolic) and status Respiration Rate Respiration rate derived from bellows or CO2 N2O Et N2O available in Agent MAC box Fi N2O not displayed O2 Inspired, end‐tidal (averaged percent) AGENT Automatic identification of primary and secondary agents (Desflurane, Isoflurane, Enflurane, Halothane or Sevoflurane) displaying both end‐tidal (Et) and fractional inspired (Fi) concentrations. Temperature Body temperature (°C or °F) ECG ECG Amplifier Protected against defibrillator and electrosurgery potentials Standard Lead Configurations I, II, III, AVR, AVL, AVF Lead Fail Passive, sensing signal imbalance ECG Input Impedance > 2.5 MΩ, single‐ended (according to IEC 60601‐2‐27, 50.102.3) Electrode Contact Impedance 20K ohms @ 10 Hz Heart Rate Resolution 1 beat per minute (BPM) Pulse Rate Range 30 to 250 BPM (Adult) 30 to 300 BPM (Neonate, Pediatric) Accuracy ± 1 percent or ± 1 BPM, whichever is greater. Expression MR400 Instructions for Use Specifications A‐7 ECG Cardiotach Sensitivity (Monitor filter mode) Adult patient type: > 200 μV Neonate/Pediatric patient type: > 100 μV QRS Duration Adult patient type: 70 to 120 ms Neonate/Pediatric patient type: 40 to 120 ms Bandwidth (Monitor filter mode) 0.5 to 40 Hz Baseline Offset Automatically removed Tall T‐Wave Rejection Capability for Heart Rate Indication 2 mV with a 1 mV QRS amplitude (Monitor mode) Leads‐off Sensing Detection by DC current waveform of < 100 nA, not applied Alarm Limits (HR) Lower Upper Off, or 30 to 250 BPM 60 to 250 BPM, or off Test/Calibrations Square Wave Test Signal 60 BPM ± 1 BPM, 1 mV ± 10 percent ECG Supplemental Information, as required by IEC 60601-2-27 Heart Rate (HR) Averaging Method Fifteen‐point median filter employed where the BPM heart rate is computed by taking the mean of the three middle elements. Update rate of the display is 2 Hz. Time to Alarm for Tachycardia B1 ‐ Vent Tachycardia 1 mVpp, 206 BPM Gain 0.5 (12.03, 11.04, 14.1, 11.8, 11.4) Average: 12.1 sec (The monitoring system may temporarily exit the alarm condition during the arrhythmia waveform duration.) Gain 1.0 (11.9, 11.6, 9.2, 9.6, 10.9) Average: 10.6 seconds Gain 2.0 (8.8, 9.1, 10.3, 9.4, 12.1) Average: 9.9 seconds B2 ‐ Vent Tachycardia 2 mVpp, 195 BPM Gain 0.5 (9.0, 10.4, 12.3, 8.1, 10.4) Average: 10.0 seconds Gain 1.0 (8.4, 7.7, 12.5, 7.7, 8.3) Average: 8.9 seconds Gain 2.0 (9.7, 12.6, 8.9, 11.8, 8.3) Average: 10.3 seconds Note Measurements made in FILTER MODE - MONITOR, outside of the MR environment. The alarm condition response time of some arrhythmia complexes may be affected by MRI gradient artifacts. Response Time of Heart Rate Meter to Change in Heart Rate A‐8 Specifications HR change from 80 to 120 BPM: 8.3 sec average HR change from 80 to 40 BPM: 7.9 sec average Expression MR400 Instructions for Use ECG Heart Rate Meter Accuracy and Response to Irregular Rhythm A1: Ventricular bigeminy: 40 BPM A2: Slow alternating ventricular bigeminy: 30 BPM A3: Rapid alternating ventricular bigeminy: 115 – 125 BPM A4: Bidirectional systoles 58 – 85 BPM Note Measurements made in FILTER MODE - MONITOR, outside of the MR environment. The accuracy of the indicated heart rate may be affected by MRI gradient artifacts. Pulse Oximeter Pulse tone pitch is modulated by the saturation value. Saturation Range 1 to 100 percent, inclusive Saturation Value Resolution 1 percent Saturation Accuracy ± 3 percent at 70 – 100 percent Pulse Accuracy ± 2 percent or ± 1 beat per minute (BPM), whichever is greater Pulse Rate Range 30 to 250 BPM, inclusive Pulse Rate Resolution 1 BPM Data Update Period 5, 10, or 15 seconds (according to the SPO2 Averaging Time setting) Data Update Period during Alarm 9, 14, or 19 seconds, maximum (4 seconds plus the SPO2 Averaging Time setting of 5, 10, or 15 seconds) Wavelength Range 500 to 1000 nm Note Information about wavelength range can be especially useful to clinicians. Emitted Light Energy < 15 mW Pulse Oximeter Calibration Range 70 to 100 percent Alarm Limits Lower Upper Expression MR400 Instructions for Use Off, or 50 to 100 percent 70 to 100 percent, or off Specifications A‐9 Pulse Oximeter When “HR” is derived from SPO2 Lower Upper Off, or 30 to 250 BPM 60 to 250 BPM, or off Note Measurement validation: SPO2 accuracy validated in human studies against arterial blood sample reference measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70–100 percent SPO2 were studied. The population characteristics for those studies were: • about 50% female and 50% male subjects • 19 – 27 years of age • light to black skin tones Reference method for the computation of pulse rate accuracy made using an electronic pulse simulator. (A functional tester cannot be used for accuracy assessment of a pulse oximeter monitor; however, it can demonstrate that a pulse oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a particular accuracy specification.) SPO2 measurements are statistically distributed; therefore, in accordance to 80601-2-61:2011, it is possible that only two-thirds of the measurements will fall within ± 3 percent of the value measured by the CO-Oximeter. CO2 (Optional LoFlo) Side stream, non‐dispersive infrared absorption technique, includes multiple filtration system and microprocessor logic control of sample handling and calibration. Method for determining end‐tidal CO2 measurement: Measures peak of the end‐tidal CO2 waveform every 20 seconds. Output CO2 waveform, EtCO2 and FiCO2 measurement numeric values, and respiration rate Initialization Time Waveform displayed in less than 20 seconds, at an ambient temperature of 25°C (77°F); full specifications attained within 2 minutes Zero Calibration Interval Automatic or user requested CO2 Unit of Measure Millimeters of mercury (mmHg) or kilopascals* (kPa) CO2 Resolution 1 mmHg (0.1 kPa) Flow Rate 50 mL/minute ± 10 mL/minute Data Sample Rate 100 Hz End‐tidal CO2 (EtCO2) Measurement Range (In which the CO2 accuracy specification is met) 0 to 76 mmHg (0 to 10.1 kPa) for respiration rates ranging from 4 to 60 breaths per minute, inclusive A‐10 Specifications Expression MR400 Instructions for Use CO2 (Optional LoFlo) Fractional inspired CO2 (FiCO2) Measurement Range CO2 Accuracy (All measurements at gas temp of 25°C) 3 to 50 mmHg (0.4 to 6.7 kPa) Method: Lowest reading of the CO2 waveform in the previous 20 seconds ± 4 mmHg (± 0.5 kPa) or ± 12 percent, whichever is greater, after the specified warm‐up period CO2 Stability Short Term Drift Not to exceed 0.8 mmHg (0.1 kPa) over a 4‐hour period Long Term Drift Accuracy specification maintained over a 120‐hour period Respiration Accuracy ± 1 breath or ± 3 percent, whichever is greater Respiration Resolution 1 breath per minute Respiration Rate Range 4 to 100 breaths per minute, inclusive (In which the respiration accuracy specification is met) Note A simulator was used to simulate breathing rates and calibrated gas was flowed through the simulator and into the system, and effects on accuracy were recorded to determine the rated respiration rate range and the corresponding effects of end-tidal gas reading accuracy as a function of respiratory rate. Accessory usage Functional without changing accessories for a minimum of 6 hours System Response and Rise Times (As measured from the patient gas input of the complete pneumatic circuit, including tubing, from 10 – 90 percent of the measured CO2 lev‐ els) Airway Adapter System response: 10.89 seconds Rise time: 0.94 seconds CO2 Cannula System response: 12.44 seconds Rise time: 1.12 seconds Divided Cannula System response: 16.17 seconds Rise time: 2.01 seconds Expression MR400 Instructions for Use Specifications A‐11 CO2 (Optional LoFlo) Compensations (Automatic CO2 ambient pressure compensation 400– 800 mmHg [53.3 – 106.6 kPa]) For end‐tidal O2 balance gas (N2, N2O, O, He) and anesthetic agentsB Uses gas compensation information to correct the raw carbon dioxide value Anesthetic Agent Effects (MAC Levels) Anesthetic Agent SensitivityA (uncompensated): Accuracy specification will be maintained for halogenated anesthetic agents present at accepted MAC (Minimum Alveolar Concentration ) clinical levels. Anesthetic Agent Sensitivity (compensated): Testing at agent levels defined by accepted regulatory standards (60601‐2‐55) Cross‐sensitivity Compensation Error (Additional worst case error when compensation for O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents present.) 0 to 40 mmHg: ± 1 mmHg additional error (0 to 5.3 kPa: ± 0.1 kPa additional error) 41 to 70 mmHg: ± 2.5 mmHg additional error (5.5 to 9.3 kPa: ± 0.3 kPa additional error) 71 to 100 mmHg: ± 4 mmHg additional error (9.5 to 13.3 kPa: ± 0.5 kPa additional error) 101 to 150 mmHg: ± 5 mmHg additional error (13.5 to 20 kPa: ± 0.6 kPa additional error) Quantitative effects of gas sample humidity or condensate**: 0 to 40 mmHg: ± 2 mmHg (0 to 5.3 kPa: ± 0.2 kPa) 41 to 70 mmHg: ± 5 percent (5.5 to 9.3 kPa: ± 5 percent) 71 to 100 mmHg: ± 8 percent (9.5 to 13.3 kPa: ± 8 percent) 101 to 150 mmHg: ± 10 percent (13.5 to 20 kPa: ± 10 percent) **With appropriate compensations applied Note There are no known adverse effects on stated performance due to cyclical pressure of up to 10 kPa (100 cmH2O). Calibration Interval A‐12 Specifications Calibration verification must be performed at 1 year intervals. Expression MR400 Instructions for Use CO2 (Optional LoFlo) Alarm Limits End‐tidal CO2 Lower Upper Off, or 5 to 60 mmHg (Off, or 0.7 to 8.0 kPa) 5 to 90 mmHg, or off (0.7 to 12.0 kPa, or off) Fractional inspired CO2 Lower Upper No low alarm; 0 to 20 mmHg, or off (0 to 2.7 kPa, or off) Respiration Lower Upper Off, or 4 to 40 RPM 20 to 100 RPM, or off *For kilopascals (kPa), allow ± 1 least significant digit to accommodate round‐off error for calculated values. A. GAS or Vapor Halothane Enflurane Isoflurane Desflurane Sevoflurane N2O 0.77 1.70 1.15 6.00 2.10 105 MAC Level, % vol fraction (From ISO 80601‐2‐55. FDA recommended for a healthy 40‐year old male.) B. Quantitative Effects of Gas or Vapor Measured Gas N2O HAL ENF ISO SEVO Xenon Helium DES Ethanol Isopropanol Acetone Methane Carbon Dioxide NE @ 60% NE 4% NE 5% NE @ 5% NE 5% ME1 80% NE @ 50% ME2 15% NE @ 0.1% NE @ 0.1% NE @ 0.1% NE @ 1% No Effect (NE) Minimal Effect 1 (ME1) = Negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38 mmHg Minimal Effect 2 (ME2) = Concentrations greater than 5% will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38 mmHg ***Metered dose inhaler propellants: Unspecified Invasive Blood Pressure (Optional) Pressure Amplifier Isolation Voltage Signal Range Sensitivity Gain Accuracy Bandwidth Expression MR400 Instructions for Use 5 KVDC ‐30 to +250 mmHg 5 µV/V/mmHg ±0.5 percent 0 to 10 Hz (‐3 dB) Specifications A‐13 Invasive Blood Pressure (Optional) Transducer Offset Range ± 300 mmHg Transducer (REF 989803179721) Operating Pressure Overpressure Limits Sensitivity Zero Offset Zero Drift Input Impedance ‐50 to 300 mmHg ‐400 to 5000 mmHg 5 µV/V/mmHg ±1 @ 6 VDC and 22°C (71.6°F) < 25 mmHg < 2 mmHg in 8 hours 300 to 350 ohms Auto Zero Range Zero Accuracy Response Time +300 mmHg ±1.0 mmHg 1 second, notifies operator when done Pressure Wave Display Number of Channels ABP, PAP and LAP CVP and ICP Pressure Scale Ranges (User Selectable) 0, 1 or 2 Numeric display of systolic, mean and diastolic pressures Numeric display of mean pressure only 0 to 250 mmHg 0 to 200 mmHg 0 to 150 mmHg 0 to 100 mmHg 0 to 75 mmHg 0 to 45 mmHg Pulse Rate (when derived from P1 or P2) Range Accuracy Resolution 30 to 250 BPM ±2 percent of full scale 1 BPM Alarm Delay Transducer Disconnect Pressure Disconnect High and Low Pressure Six seconds Six seconds Ten seconds Alarm Limits When “HR” is derived from P1 or P2 Lower Upper Systolic, Mean, Diastolic Lower Upper A‐14 Specifications Off, or 30 to 250 BPM 60 to 250 BPM, or off Off, or ‐30 mmHg to 250 mmHg (Off, or ‐4.0 to 33.3 kPa) ‐30 mmHg to 250 mmHg, or off (‐4.0 to 33.3 kPa, or off) Expression MR400 Instructions for Use Invasive Blood Pressure (Optional) Transducer Adapter Cable Compatibility Invasive pressure input mates with an Amphenol connector (MS‐3106A 14S‐6P). With this connector and the following connection information, transducer adapter cables may be fabricated or ordered from various manufacturers. Connector Pin Number Signal Name ‐ Signal + Excitation + Signal ‐ Excitation Shield AGENT (Optional) Side Stream, non‐dispersive infrared (NDIR) absorption technique, including water trap filtration system and microprocessor logic control of sample handling and calibration Simultaneously measured gases Any two of the following, inspired or expired, while also measuring CO2, N2O, and O2: Halothane Isoflurane Sevoflurane Desflurane Enflurane Measurement Range (after maximum warm‐ up period) Halothane: 0 to 5.0 Vol.% Isoflurane: 0 to 5.0 Vol.% Sevoflurane: 0 to 8.0 Vol.% Desflurane: 0 to 18.0 Vol.% Enflurane: 0 to 5.0 Vol.% Carbon Dioxide: 0 to 10.0 Vol.% Nitrous Oxide: 0 to 100 Vol.% Expression MR400 Instructions for Use Specifications A‐15 AGENT (Optional) Accuracy* (includes stability and drift) ±0.15 Vol.% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% Unspecified > 5.00 Isoflurane: ±0.15 Vol.% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% Unspecified > 5.00 Sevoflurane: ±0.15 Vol.% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% ±0.40 Vol% at 5.00 to 8.00 Vol% Unspecified > 8.00 Desflurane: ±0.15 Vol% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% ±0.40 Vol% at 5.00 to 10.00 Vol% ±0.60 Vol% at 10.00 to 15.00 Vol% ±1.0 Vol% at 15.00 to 18.00 Vol% Unspecified > 18.00 Enflurane: ±0.15 Vol.% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% Unspecified > 5.00 Carbon Dioxide: ±0.10 Vol% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% ±0.30 Vol% at 5.00 to 7.00 Vol% ±0.50 Vol% at 7.00 to 10.00 Vol% Unspecified > 10.00 Nitrous Oxide: ±2.00 Vol% at 0 to 20 Vol% ±3.00 Vol% at 20.0 to 100 Vol% Interference Gas CO2: N2O, O2, Any Agent = 0.1%ABS inaccuracy allowance for each N2O: CO2, O2, Any Agent = 0.1%ABS inaccuracy allowance for each Agents: CO2 = 0%ABS inaccuracy allowance N2O, O2, 2nd Agent = 0.1%ABS inaccuracy allowance for each Flow Rate (fixed) 200 ± 20 ml/min (Adult, Pediatric) 150 ± 15 ml/min (Neonate) Maximum specified interval for intervention of water (hours at specified minimum sample flow rate) AGENT mode: Adult and pediatric is 17 hours @ 200 ml/min, 37°C, 100% RH; neonate is 17 hours @ 120 ml/min, 37°C, 100% RH A‐16 Specifications Halothane: CO2 mode: 8 hours @ 50 mL/min +/‐ 10 ml/min Expression MR400 Instructions for Use AGENT (Optional) System Response and Rise Times (As measured from patient gas input of the complete pneumatic circuit, including tubing, from 10 – 90 percent of measured levels) Cannula, Adult Halothane— System response: 11.56 seconds Rise time: 5.77 seconds Enflurane— System response: 7.55 seconds Rise time: 1.75 seconds Isoflurane— System response: 6.71 seconds Rise time: 0.88 seconds Sevoflurane— System response: 6.45 seconds Rise time: 0.62 seconds Desflurane— System response: 6.63 seconds Rise time: 0.57 seconds Oxygen— System response: 6.99 seconds Rise time: 1.02 seconds Nitrous oxide— System response: 6.28 seconds Rise time: 0.25 seconds CO2— System response: 6.62 seconds Rise time: 0.61 seconds Expression MR400 Instructions for Use Specifications A‐17 AGENT (Optional) Cannula, Infant Halothane— System response: 15.95 seconds Rise time: 8.63 seconds Enflurane— System response: 11.98 seconds Rise time: 4.75 seconds Isoflurane— System response: 9.26 seconds Rise time: 1.70 seconds Sevoflurane— System response: 6.48 seconds Rise time: 0.62 seconds Desflurane— System response: 6.47 seconds Rise time: 0.61 seconds Oxygen— System response: 8.61 seconds Rise time: 1.13 seconds Nitrous oxide— System response: 7.95 seconds Rise time: 0.72 seconds CO2— System response: 6.51 seconds Rise time: 0.48 seconds A‐18 Specifications Expression MR400 Instructions for Use AGENT (Optional) Divided Cannula, Adult Halothane— System response: 20.81 seconds Rise time: 14.18 seconds Enflurane— System response: 13.83 seconds Rise time: 7.11 seconds Isoflurane— System response: 10.99 seconds Rise time: 3.91 seconds Sevoflurane— System response: 7.48 seconds Rise time: 0.78 seconds Desflurane— System response: 7.38 seconds Rise time: 0.64 seconds Oxygen— System response: 8.02 seconds Rise time: 1.07 seconds Nitrous oxide— System response: 7.16 seconds Rise time: 0.51 seconds CO2— System response: 7.57 seconds Rise time: 0.64 seconds Expression MR400 Instructions for Use Specifications A‐19 AGENT (Optional) Divided Cannula, Infant Halothane— System response: 9.98 seconds Rise time: 3.95 seconds Enflurane— System response: 7.32 seconds Rise time: 1.37 seconds Isoflurane— System response: 6.75 seconds Rise time: 0.89 seconds Sevoflurane— System response: 5.45 seconds Rise time: 0.67 seconds Desflurane— System response: 6.25 seconds Rise time: 0.60 seconds Oxygen— System response: 7.25 seconds Rise time: 0.84 seconds Nitrous oxide— System response: 6.51 seconds Rise time: 0.39 seconds CO2— System response: 5.49 seconds Rise time: 0.49 seconds Data Sample Rate 25 Hz Full Accuracy Respiration Rate (Range permitting specified gas accuracy) 2 to 60 rpm Note A simulator was used to simulate breathing rates and calibrated gas was flowed through the simulator and into the system, and effects on accuracy were recorded to determine the rated respiration rate range and the corresponding effects of end-tidal gas reading accuracy as a function of respiratory rate. End‐tidal gas readings, calculation method End tidal CO2 concentration readings are identified by using the highest value of the temporal CO2‐curve. Corresponding readings of N2O and anesthetic agents are taken at the same point in time. End‐ tidal O2 concentration readings are identified by the O2 mean value during the respiratory phase as identified by the temporal CO2 curve. Once correctly identified, the lowest O2 concentration reading during the phase will be presented as end‐tidal O2. Total Respiration Range 2 to 100 rpm; accuracy is unspecified from 60 to 100 rpm A‐20 Specifications Expression MR400 Instructions for Use AGENT (Optional) Relevant Interference 0.5 mmHg equivalent with 37.5°C saturated with H2O (0.1% relative max) Display Resolution 0.1 percent volume Maximum Warm‐up Time 10 minutes; ISO accuracy achieved in < 45 seconds of activation Auto ID Threshold (full accuracy mode) Primary Agent ID: 0.15% Secondary Agent ID: 0.3% Multiple Agents Alarm Threshold 0.3% (0.5% during ISO accuracy mode) or 5%REL (10% for Isoflurane) of primary agent if primary agent > 10% (For Hal add 0.1%ABS to threshold values) CO2 Ambient Pressure Compensation Range 500 mmHg to 900 mmHg Pressure Compensation Unaffected by cyclical pressures of up to 10 kPa as, apart from the described automatic pressure compensation, the pump automati‐ cally regulates flow so that not only gas readings but also gas sample flow is unaffected Calibration Interval Calibration verification must be performed at 1 year intervals. Alarm Limits Et CO2 Lower Upper Off, or 5 to 60 mmHg (Off, or 0.6 – 8.0 kPa) 5 to 90 mmHg, or off (0.7 – 12.0 kPa, or off) Fi CO2 Lower Upper No low alarm; 0 to 20 mmHg, or off (0 to 2.7 kPa, or off) Fi N2O Lower Upper No low alarm; 0 to 80 percent Et Halothane Lower Upper Off, or 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, or off Fi Halothane Lower Upper Off, or 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, or off Et Isoflurane Lower Upper Off, or 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, or off Expression MR400 Instructions for Use Specifications A‐21 AGENT (Optional) Fi Isoflurane Lower Upper Off, 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, Off Et Enflurane Lower Upper Off, 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, Off Fi Enflurane Lower Upper Off, 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, Off Et Sevoflurane Lower Upper Off, 0.1 to 8.0 Vol. % 0.1 to 8.0 Vol. %, Off Fi Sevoflurane Lower Upper Off, 0.1 to 8.0 Vol. % 0.1 to 8.0 Vol. %, Off Et Desflurane Lower Upper Off, 0.1 to 18.0 Vol. % 0.1 to 18.0 Vol. %, Off Fi Desflurane Lower Upper Off, 0.1 to 18.0 Vol. % 0.1 to 18.0 Vol. %, Off Fi O2 Lower and upper 18 to 100 percent O2 Resolution 1 percent Range 0 to 100 percent Signal Output (at constant temperature and pressure) 10 mV ±1.5 mV @ 20°C / 20.95% O2 Maximum Response Time (21% to 100% step change through patient sampling line as seen in WPU gas monitor window) Adult/Pediatric < 7.3 seconds Neonate: < 8.2 seconds Accuracy (includes stability and drift), full scale* ±1% at 0 to 40% ±2% at 40 to 60% ±3% at 60 to 80% ±4% at 80 to 100% *Gas measurement performance requirements are met after the maximum warm‐up period. A‐22 Specifications Expression MR400 Instructions for Use AGENT (Optional) Offset ±1 percent O2 Interfering Gas Effects: N2O CO2 Halothane Enflurane Isoflurane Desflurane Sevoflurane Acetone Ethanol Helium Methane Nitric Oxide < 0.3 vol% @ 80 vol% N2O < 0.3 vol% @ 5 vol% CO2 < 0.3 vol% @ 5 vol% HAL < 0.3 vol% @ 5 vol% ENF < 0.3 vol% @ 5 vol% ISO < 0.3 vol% @ 18 vol% DES < 0.3 vol% @ 8 vol% SEV < 0.3 vol% @ 1 vol% Acetone < 0.3 vol% @ 0.1 vol% Ethanol < 0.3 vol% @ 80 vol% HE < 0.3 vol% @ 0.1 vol% Methane < 0.3 vol% @ 50 ppm NO Oxygen Sensor, Operating Temperature 15 to 35°C (59 to 95°F) Oxygen Sensor, Expected Operating Life Product labeled with a use‐by date; 15 months from manufacturing date (2500 hours at 100 percent O2). Exchange recommended every 12 months. CO2 Resolution 1 percent Range 0 to 100 percent Bellows Respiration Respiration Rate Measurement Range 0 to 60 breaths per minute Respiration Rate Resolution 1 breath per minute Respiration Rate Accuracy ± 1 breath per minute Temperature (Optional) (All measurements made with or without a sterile jacket) Channel One Units Celsius (°C) or Fahrenheit (°F) Range 20.0°C to 44.0°C (68.0°F to 111.2°F) Resolution 0.1°C (0.1°F) Expression MR400 Instructions for Use Specifications A‐23 Temperature (Optional) (All measurements made with or without a sterile jacket) Accuracy ±0.5°C (±0.9°F) Confirming changes in a measurement against other vital sign mea‐ surements should be standard routine during use. Response Time The measuring time to obtain a steady‐state reading within the manufacturer’s accuracy specifications is within 15 seconds, compliant to ISO 80601‐2‐56, Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. Numeric Display Update Time 2 seconds Sensor Type Fiber‐optic, multiple‐use (when used with single‐use sterilized jack‐ ets) Application Site Axillary, esophageal, rectal Measurement Mode Direct Alarm Limits Lower Upper Off, or 20.0 to 44.0°C (Off, or 68.0 to 111.2°F) 20.0 to 44.0°C, or off (68.0 to 111.2°F, or off) Non-Invasive Blood Pressure Oscillometric technology (with an inflatable cuff) determines systolic, diastolic and mean arterial pressures Patient Types Adult, Pediatric and Neonate Pneumatic Systems Cuff Inflation Pressure Initial: 165 mmHg (22 kPa) for Adult, 130 mmHg (17.3 kPa) for Pediatric, and 100 mmHg (13.3 kPa) for Neonate; all pressures are ± 15 mmHg (2 kPa) Subsequent inflation pressures determined by last NIBP measurement Overpressure Protection Automatic cuff pressure release if inflation pressure exceeds 300 mmHg (40 kPa) for Adult and Pediatric modes, and 150 mmHg (20 kPa) for Neonate mode Unit of Measure Millimeters of mercury (mmHg) or kilopascals* (kPa) Measurement Range Systolic Adult Pediatric Neonate A‐24 Specifications 30 to 270 mmHg (4.0 to 36 kPa) 30 to 180 mmHg (4.0 to 24 kPa) 30 to 130 mmHg (4.0 to 17.3 kPa) Expression MR400 Instructions for Use Non-Invasive Blood Pressure Mean Adult Pediatric Neonate 20 to 255 mmHg (2.7 to 34 kPa) 20 to 160 mmHg (2.7 to 21.3 kPa) 20 to 120 mmHg (2.7 to 16 kPa) Diastolic Adult Pediatric Neonate 10 to 245 mmHg (1.3 to 32.7 kPa) 10 to 150 mmHg (1.3 to 20 kPa) 10 to 100 mmHg (1.3 to 13.3 kPa) Accuracy Pressure Measurement Accuracy Maximum mean error ± 5 mmHg (± 0.6 kPa) with a standard deviation of less than 8 mmHg (1 kPa) Pressure Measurement Resolution 1 mmHg (0.1 kPa) Pressure Transducer Range 0 to 300 mmHg (0 to 40 kPa) Modes Manual Immediate upon operator command Automatic Determinations automatically made with selectable intervals of 1, 2, 3, 5, 10, 15, 20, and 30 minutes Expression MR400 Instructions for Use Specifications A‐25 Non-Invasive Blood Pressure Notes • The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the exclusion criteria. • The NIBP clinical study was performed on adult and pediatric patients with the following attributes: – The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the exclusion criteria.Gender: 61% male, 39% female. – No patients less than 29 days of age. – Patients with limb circumferences ranged from 10.5 cm to 39 cm, with a distribution of 46 percent below 25 cm and 7 percent above 35 cm. – The arterial systolic pressure ranges from 58 mmHg to 211 mmHg, with an average of 115 mmHg and with a distribution of 32.7 percent below 100 mmHg and 2.4 percent above 180 mmHg. The arterial diastolic pressure ranges from 34 mmHg to 131 mmHg, with an average of 65 mmHg and with a distribution of 42.3 percent below 60 mmHg and 3.9 percent above 100 mmHg. – Patients with any sign of arterial disease were excluded. – Patients with a heart beat greater than 180 BPM were excluded. – The radial artery was acceptable as a reference site for all patients but one which used the femoral artery. – The effectiveness was not validated on pregnant, including pre-eclamptic, patient populations. • The NIBP clinical study was performed on neonatal patients with the following attributes: – No specified gender. – All patients 28 days or less if born at term (37 gestation or more); otherwise, up to 44 gestational weeks. – Patients with limb circumferences ranged from 5.75 cm to 13 cm with an average of 7.9 cm. – The arterial systolic pressure ranged from 42 mmHg to 89 mmHg, with an average of 57 mmHg. The arterial diastolic pressure ranged from 20 mmHg to 62 mmHg, with an average of 34 mmHg. • Arterial reference sites included the umbilical, femoral, brachial and radial artery. A‐26 Specifications Expression MR400 Instructions for Use Non-Invasive Blood Pressure Alarm Limits Systolic Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Mean Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Diastolic Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Off, or 30 to 270 mmHg (Off, or 4.0 to 36.0 kPa) 30 to 270 mmHg, or off (or 4.0 to 36.0 kPa, or off) Off, or 30 to 180 mmHg (Off, or 4.0 to 24.0 kPa) 30 to 180 mmHg, or off (or 4.0 to 24.0 kPa, or off) Off, or 30 to 130 mmHg (Off, or 4.0 to 17.3 kPa) 30 to 130 mmHg, or off (4.0 to 17.3 kPa, or off) Off, or 20 to 255 mmHg (Off, or 2.7 to 34.0 kPa) 20 to 255 mmHg, or off (2.7 to 34.0 kPa, or off) Off, or 20 to 160 mmHg (Off, or 2.7 to 21.3 kPa) 20 to 160 mmHg, or off (2.7 to 21.3 kPa, or off) Off, or 20 to 120 mmHg (Off, or 2.7 to 16.0 kPa) 20 to 120 mmHg, or off (2.7 to 16.0 kPa, or off) Off, or 10 to 245 mmHg (Off, or 1.3 to 32.7 kPa) 10 to 245 mmHg, or off (1.3 to 32.7 kPa, or off) Off, or 10 to 150 mmHg (Off, or 1.3 to 20.0 kPa) 10 to 150 mmHg, or off (1.3 to 20.0 kPa, or off) Off, or 10 to 100 mmHg (Off, or 1.3 to 13.3 kPa) 10 to 100 mmHg, or off (1.3 to 13.3 kPa, or off) *For kilopascals (kPa), allow ± 1 least significant digit to accommodate round‐off error for calculated values. Expression MR400 Instructions for Use Specifications A‐27 Gating Outputs Gating connector pin-outs Pin Designator Signal Name Description and Characteristics Digital gating pulse ECG/SPO2 digital gating pulse: • Peak to peak voltage: 3.3 V to 5.0 V • Pulse duration: 10 ± 3 ms • Delay < 10 ms, ECG: Monitor and Default filter modes • Delay < 12 ms, ECG: Advanced 1 filter mode • Delay < 14 ms, ECG: Advanced 2 filter mode • Delay < 50 ms, SPO2 Signal ground Return voltage reference for all other signal pins RESP 1 V Analog Analog respiration gating waveform signal: • Maximum output voltage: ± 5 V • Maximum current: 5 mA • Peak‐to‐peak signal voltage: 1 V • Delay = 200 ms ECG 1 V Analog Analog ECG 1‐Volt waveform signal: • Bandwidth 0.5 to 40 Hz (Monitor filter mode) • Output signal scaling: 1 V/mV • Maximum output voltage: ± 5 V • Maximum current: 5 mA • Delay < 10 ms P1 200mV Analog Analog P1 gating waveform signal: • Maximum output voltage: 200 mV Negative gating pulse ECG/SPO2 negative digital gating pulse: • Peak‐to‐peak signal voltage: ‐3.3 V to ‐5.0 V • All other signal characteristics same as Pin A (see above) SPO2 40 mV Analog SPO2 IR/red analog gating waveform signal: • Signal scaling: 1 V/mV • Maximum output voltage: 40 mV • Delay = 250 ms ECG 1 mV Analog ECG analog gating waveform signal: • Signal scaling: 1 mV/mv • Maximum current: 5 mA • Maximum output voltage: 20 mV • Bandwidth 0.5 to 40 Hz (Monitor filter mode) • Delay < 10 ms SPO2 2 V Analog SPO2 IR/red analog gating waveform signal: • Maximum output voltage: 2 V • Delay = 250 ms Unused Unused pins K, L, M, N, O A‐28 Specifications Expression MR400 Instructions for Use APPENDIX B Warranty Warranty Statement Koninklijke Philips N.V. warrants this product, other than its consumable parts, to be free from defects in materials and workmanship for a period of twelve (12) months from the date of original delivery to the buyer or to buyer's order, provided that same is properly operated under conditions of normal use, and that periodic maintenance and service is performed. This same warranty is made for a period of ninety (90) days on consumable parts. This warranty shall become null and void if the MR400 has been repaired by someone other than Koninklijke Philips N.V. or if the product has been subject to misuse, accident, negligence or abuse. Koninklijke Philips N.V.’s sole obligation under this warranty is limited to repairing an MR400 which has been reported to the Technical Service Center during normal business hours and shipped transportation prepaid. Koninklijke Philips N.V. shall not be liable for any damages including but not limited to incidental damages, consequential damages or special damages. This warranty is in lieu of any other warranties, guarantees or conditions, including merchantability or fitness for a particular purpose. The remedies under this warranty are exclusive and Koninklijke Philips N.V. neither assumes nor authorizes anyone to assume for it any other obligation in connection with the sale or repair of its products. KONINKLIJKE PHILIPS N.V. PRODUCTS CONTAIN PROPRIETARY COPYRIGHTED MATERIAL. ALL RIGHTS RESERVED Expression MR400 Instructions for Use Warranty B‐1 B‐2 Warranty Expression MR400 Instructions for Use APPENDIX C Regulatory Information European Union Declaration of Conformity To obtain a copy of the Declaration of Conformity to the European Union Medical Device Directive (93/42/EEC) and Radio & Telecommunications Terminal Equipment Directive (1999/5/ EC), and/or Restriction on Hazardous Substance (RoHS) Directive, contact the Regulatory Affairs Department at Invivo: 407‐275‐3220 ‐or‐ 1‐800‐331‐3220 (toll‐free) Internationally, please contact your Key Market representative. Go to www.invivocorp.com for a listing. In addition, copies may be obtained from InCenter. Authorized Representative The Authorized Representative for the European Union (as required by the Medical Device Directive, 93/42/EEC) is as follows: Philips Medizin Systeme Böblingen GmbH Hewlett‐Packard Straße 2 71034, Böblingen Germany Australia The Australia Sponsor is as follows: Philips Electronics Australia Ltd 65 Epping Road, North Ryde NSW 2113 Australia Expression MR400 Instructions for Use Regulatory Information C‐1 C‐2 Regulatory Information Expression MR400 Instructions for Use APPENDIX D Gating Feature The gating feature in the MR400 outputs data and discrete signals to the MRI scanner system resulting from the collection and processing of data from a monitored parameter. The scanner system uses these signals and data to precisely control the times that it collects MR image data from the patient. Two types of data can be output by the gating facility of the MR400: • Analog waveforms, which are analog electronic representations of waveforms collected from monitored parameters; and, • Gating pulses, which are discrete electronic signals that indicate that some physiological event associated with a monitored parameter has occurred. MR400 Preparation for Gating When preparing the MR400 for gating of the MR system, ensure that the correct type of gating cable is connected between the rear panel of the MR400 and the MR system. Gating connector for connection of the gating cable to the MR system. Gating Connector Pin-outs Gating signals from the MR400 are available through the shielded gating connector located on the rear panel of the cart (see above). Connections are made using a gating cable. Gating cables are available for each manufacturer’s MRI system (GE Horizon LX, Siemens Harmony, Siemens Expression MR400 Instructions for Use Gating Feature D‐1 Symphony, Siemens Alvanto, Philips Intera, et cetera; see page 1‐35). For detailed signal characteristics of the gating outputs, see A‐28. Using the Gating Feature The gating feature provides facilities for low latency MRI triggering and synchronization based on the measured ECG or SPO2 signal. Data measured and transmitted by the wECG or wSpO2 module is processed by the MR400 and output at the gating connector; see page 1‐19 for the location, and see the table at the end of this appendix for signal details. (Signals can also transmitted by the optional wBTU.) Using ECG Gating To receive ECG gating signals Step Action Check the battery indicators on the wECG module to ensure that enough charge exists in at least one of the installed batteries: • Green battery indicator = Charge sufficient; proceed to step 3. • Red battery indicator = Charge low; proceed to step 2. See page 2‐9 for details. (Also, you can reference the status information pane; see page 2‐16.) According to the red battery indicator(s) present on the wECG module, insert a charged module battery into the corresponding battery bay(s) and then recheck the battery indicator(s) to ensure a sufficient charge before proceeding; see page 1‐24. Check the network channel indicator on the wECG module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 5. • Flashing = No communication; proceed to step 4. See page 2‐10 for details. (Also, you can reference the status information pane; see page 2‐16.) Ensure that the wECG module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. Ensure that the lead cable is properly attached to the patient; see Attaching the ECG Lead Cable on page 5‐12. (ECG outputs are enabled by default; see page 5‐29.) D‐2 Gating Feature It may be necessary to use T‐Wave Suppression, see page 5‐33. Expression MR400 Instructions for Use Step Action Proceed according to the type of gating being used: Analog Gating — To receive the analog ECG gating waveform through the MR400, ensure that all of the following conditions have been met: • The correct gating cable is installed between the MR400 and the MR system; • The system is communicating with the wECG module; • The wECG module is properly attached to the patient; and, • Lead Fail does not exist for the measured ECG signal. Digital Gating — To receive the digital ECG gating pulse from the MR400, ensure that all of the following conditions have been met: • The correct gating cable is installed between the MR400 and the MR system; • The system is communicating with the wECG module; • The wECG module is properly attached to the patient; • Lead Fail does not exist for the measured ECG signal; • The ECG parameter has been activated in the menu system; and, • The ECG signal has been selected as the digital pulse source, as follows: a. Select the ECG VS box. b. Select Gating Source. c. Select ECG. Expression MR400 Instructions for Use Gating Feature D‐3 Using SPO2 Gating To receive SPO2 gating signals Step Action Check the battery indicator on the wSpO2 module to ensure that enough charge exists: • Green battery indicator = Charge sufficient; proceed to step 5. • Red battery indicator = Charge low; proceed to step 4. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Insert a charged module battery into the wSpO2 module and then recheck the battery indicator to ensure a sufficient charge before proceeding; see page 1‐26. Check the network channel indicator on the wSpO2 module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 7. • Flashing = No communication; proceed to step 6. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) Ensure that the correct gating cable is installed between the MR400 and the MR system. Ensure that the wSpO2 module is within 9.1 m (30 feet) of the MR400, in the same MRI room or in the same shielded room, and is set to the same wireless network channel used by the MR400; see page 1‐29. Ensure that the SPO2 attachment is properly attached; see Apply‐ ing the SPO2 Attachment to the Patient on page 6‐3. Select the SPO2 VS box (see page 6‐8). The SPO2 menu appears. Current settings are displayed. Select Gating Source. The Gating Source menu appears; see page 5‐15. Select Pulse. The setting is applied. D‐4 Gating Feature Expression MR400 Instructions for Use APPENDIX E Guidelines and References Guidelines for the Prevention of Excessive Heating and Burns Associated with Magnetic Resonance Procedures In general, magnetic resonance (MR) imaging is considered to be a relatively safe diagnostic modality. However, the use of radio frequency coils, physiologic monitors, electronically‐ activated devices, and external accessories or objects made from conductive materials has caused excessive heating, resulting in burn injuries to patients undergoing MR procedures. Heating of implants and similar devices may also occur in association with MR procedures, but this tends be problematic primarily for objects made from conductive materials that have elongated shapes such as leads, guide wires, and certain types of catheters (e.g., catheters with thermistors or other conducting components). Notably, more than 30 incidents of excessive heating have been reported in patients undergoing MR procedures in the United States that were unrelated to equipment problems or the presence of conductive external or internal implants or materials [review of data files from U.S. Food and Drug Administration, Center for Devices and Radiological Health, Manufacturer and User Facility Device Experience Database, MAUDE, http://www.fda.gov/cdrh/maude.html and U.S. Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Report, (http:// www.fda.gov/CDRH/mdrfile.html)]. These incidents included first, second, and third degree burns that were experienced by patients. In many of these cases, the reports indicated that the limbs or other body parts of the patients were in direct contact with body radio frequency (RF) coils or other RF transmit coils of the MR systems or there were skin‐to‐skin contact points suspected to be responsible for these injuries. MR systems require the use of RF pulses to create the MR signal. This RF energy is transmitted readily through free space from the transmit RF coil to the patient. When conducting materials are placed within the RF field, the result may be a concentration of electrical currents sufficient to cause excessive heating and tissue damage. The nature of high frequency electromagnetic fields is such that the energy can be transmitted across open space and through insulators. Therefore, only devices with carefully designed current paths can be made safe for use during MR procedures. Simply insulating conductive material (e.g., wire or lead) or separating it from the patient may not be sufficient to prevent excessive heating or burns from occurring. Furthermore, certain geometrical shapes exhibit the phenomenon of “resonance” which increases their propensity to concentrate RF currents. At the operating frequencies of present day MR systems, conducting loops of tens of centimeters in size may create problems and, therefore, must be avoided, unless high impedance is used to limit RF current. Importantly, even loops that include small gaps separated by insulation may still conduct current. To prevent patients from experiencing excessive heating and possible burns in association with MR procedures, the following guidelines are recommended: Expression MR400 Instructions for Use Guidelines and References E‐1 1. Prepare the patient for the MR procedure by ensuring that there are no unnecessary metallic objects contacting the patient's skin (e.g., metallic drug delivery patches, jewelry, necklaces, bracelets, key chains, et cetera). 2. Prepare the patient for the MR procedure by using insulation material (i.e., appropriate padding) to prevent skin‐to‐skin contact points and the formation of “closed‐loops” from touching body parts. 3. Insulating material (minimum recommended thickness, 1 cm) should be placed between the patient's skin and transmit RF coil that is used for the MR procedure (alternatively, the RF coil itself should be padded). For example, position the patient so that there is no direct contact between the patient's skin and the body RF coil of the MR system. This may be accomplished by having the patient place his/her arms over his/her head or by using elbow pads or foam padding between the patient's tissue and the body RF coil of the MR system. This is especially important for those MR examinations that use the body coil or other large RF coils for transmission of RF energy. 4. Use only electrically conductive devices, equipment, accessories (e.g., ECG leads, electrodes, et cetera), and materials that have been thoroughly tested and determined to be safe and compatible for MR procedures, as listed in this IFU. 5. Carefully follow specific MR safety criteria and recommendations for implants made from electrically‐conductive materials (e.g., bone fusion stimulators, neurostimulation systems, et cetera). 6. Before using electrical equipment, check the integrity of the insulation and/or housing of all components including surface RF coils, monitoring leads, cables, and wires. Preventive maintenance should be practiced routinely for such equipment. 7. Remove all non‐essential electrically conductive materials from the MR system (i.e., unused surface RF coils, ECG leads, cables, wires, et cetera). 8. Keep electrically conductive materials that must remain in the MR system from directly contacting the patient by placing thermal and/or electrical insulation between the conductive material and the patient. 9. Keep electrically conductive materials that must remain within the body RF coil or other transmit RF coil of the MR system from forming conductive loops. Note: The patient's tissue is conductive and, therefore, may be involved in the formation of a conductive loop, which can be circular, U‐shaped, or S‐shaped. 10. Position electrically conductive materials to prevent “cross points”. For example, a cross point is the point where a cable crosses another cable, where a cable loops across itself, or where a cable touches either the patient or sides of the transmit RF coil more than once. Notably, even the close proximity of conductive materials with each other should be avoided because some cables and RF coils can capacitively‐couple (without any contact or crossover) when placed close together. 11. Position electrically conductive materials to exit down the center of the MR system (i.e., not along the side of the MR system or close to the body RF coil or other transmit RF coil). E‐2 Guidelines and References Expression MR400 Instructions for Use 12. Do not position electrically conductive materials across an external metallic prosthesis (e.g., external fixation device, cervical fixation device, et cetera) or similar device that is in direct contact with the patient. 13. Allow only properly trained individuals to operate devices (e.g., monitoring equipment) in the MR environment. 14. Follow all manufacturer instructions for the proper operation and maintenance of physiologic monitoring or other similar electronic equipment intended for use during MR procedures. 15. Electrical devices that do not appear to be operating properly during the MR procedure should be removed from the patient immediately. 16. Closely monitor the patient during the MR procedure. If the patient reports sensations of heating or other unusual sensation, discontinue the MR procedure immediately and perform a thorough assessment of the situation. 17. RF surface coil decoupling failures can cause localized RF power deposition levels to reach excessive levels. The MR system operator will recognize such a failure as a set of concentric semicircles in the tissue on the associated MR image or as an unusual amount of image non‐uniformity related to the position of the RF coil. The adoption of these guidelines will help to ensure that patient safety is maintained, especially as more conductive materials and electronically‐activated devices are used in association with MR procedures. References Bashein G, Syrory G. Burns associated with pulse oximetry during magnetic resonance imaging. Anesthesiology 1991;75:382‐3. Brown TR, Goldstein B, Little J. Severe burns resulting from magnetic resonance imaging with cardiopulmonary monitoring. Risks and relevant safety precautions. Am J Phys Med Rehabil 1993;72:166‐7. Chou C‐K, McDougall JA, Chan KW. Absence of radiofrequency heating from auditory implants during magnetic resonance imaging. Bioelectromagnetics 1997;44:367‐372. Dempsey MF, Condon B. Thermal injuries associated with MRI. Clin Radiol 2001;56:457‐65. Dempsey MF, Condon B, Hadley DM. Investigation of the factors responsible for burns during MRI. J Magn Reson Imaging 2001;13:627‐631. ECRI, Health Devices Alert. A new MRI complication? Health Devices Alert. May 27, pp. 1, 1988. ECRI. Thermal injuries and patient monitoring during MRI studies. Health Devices Alert. 1991;20: 362‐363. Expression MR400 Instructions for Use Guidelines and References E‐3 Finelli DA, Rezai AR, Ruggieri PM, Tkach JA, Nyenhuis JA, Hrdlicka G, Sharan A, Gonzalez‐Martinez J, Stypulkowski PH, Shellock FG. MR imaging‐related heating of deep brain stimulation electrodes: In vitro study. Am J Neuroradiol 2002;23:1795‐1802. Heinz W, Frohlich E, Stork T. Burns following magnetic resonance tomography study. (German) Z Gastroenterol 1999;37:31‐2. http://www.MRIsafety.com International Electrotechnical Commission (IEC), Medical Electrical Equipment, Particular requirements for the safety of magnetic resonance equipment for medical diagnosis, International Standard IEC 60601‐2‐33, 2002. Jones S, Jaffe W, Alvi R. Burns associated with electrocardiographic monitoring during magnetic resonance imaging. Burns 1996;22:420‐1. Kanal E, Shellock FG. Burns associated with clinical MR examinations. Radiology 1990;175: 585. Kanal E, Shellock FG. Policies, guidelines, and recommendations for MR imaging safety and patient management. J Magn Reson Imaging 1992;2:247‐248. Keens SJ, Laurence AS. Burns caused by ECG monitoring during MRI imaging. Anaesthesia 1996;51:1188‐9. Knopp MV, Essig M, Debus J, Zabel HJ, van Kaick G. Unusual burns of the lower extremities caused by a closed conducting loop in a patient at MR imaging. Radiology 1996;200:572‐5. Knopp MV, Metzner R, Brix G, van Kaick G. Safety considerations to avoid current‐induced skin burns in MRI procedures. (German) Radiologe 199838:759‐63. Kugel H, Bremer C, Puschel M, Fischbach R, Lenzen H, Tombach B, Van Aken H, Heindel W. Hazardous situation in the MR bore: induction in ECG leads causes fire. Eur Radiol 2003;13:690‐ 694. Nakamura T, Fukuda K, Hayakawa K, Aoki I, Matsumoto K, Sekine T, Ueda H, Shimizu Y. Mechanism of burn injury during magnetic resonance imaging (MRI)‐simple loops can induce heat injury. Front Med Biol Eng 2001;11:117‐29 Nyenhuis JA, Kildishev AV, Foster KS, Graber G, Athey W. Heating near implanted medical devices by the MRI RF‐magnetic field. IEEE Trans Magn 1999;35:4133‐4135. Rezai AR, Finelli D, Nyenhuis JA, Hrdlick G, Tkach J, Ruggieri P, Stypulkowski PH, Sharan A, Shellock FG. Neurostimulator for deep brain stimulation: Ex vivo evaluation of MRI‐related heating at 1.5‐Tesla. Journal of Magnetic Resonance Imaging 2002;15:241‐250. Schaefer DJ. Safety Aspects of radio‐frequency power deposition in magnetic resonance. MRI Clinics of North America 1998;6:775‐789. Schaefer DJ, Felmlee JP. Radio‐frequency safety in MR examinations, Special Cross‐Specialty Categorical Course in Diagnostic Radiology: Practical MR Safety Considerations for Physicians, Physicists, and Technologists, Syllabus, 87th Scientific of the Radiological Society of North America, Chicago, pp 111‐123, 2001. Shellock FG. Magnetic Resonance Procedures: Health Effects and Safety. CRC Press, LLC, Boca Raton, FL, 2001. E‐4 Guidelines and References Expression MR400 Instructions for Use Shellock FG. MR safety update 2002: Implants and devices. Journal of Magnetic Resonance Imaging 2002;16:485‐496. Shellock FG. Radiofrequency‐induced heating during MR procedures: A review. Journal of Magnetic Resonance Imaging 2000;12: 30‐36. Shellock FG. Reference Manual for Magnetic Resonance Safety: 2003 Edition, Amirsys, Inc., 2003. Shellock FG, Slimp G. Severe burn of the finger caused by using a pulse oximeter during MRI. American Journal of Roentgenology 1989;153:1105. Shellock FG, Hatfield M, Simon BJ, Block S, Wamboldt J, Starewicz PM, Punchard WFB. Implantable spinal fusion stimulator: assessment of MRI safety. Journal of Magnetic Resonance Imaging 2000;12:214‐223. Smith CD, Nyenhuis JA, Kildishev AV. Health effects of induced electrical fields: implications for metallic implants. In: Shellock FG, ed. Magnetic resonance procedure: health effects and safety. Boca Raton, FL: CRC Press, 2001; 393‐414. U.S. Food and Drug Administration, Center for Devices and Radiological Health (CDRH), Medical Device Report (MDR) (http://www.fda.gov/CDRH/mdrfile.html). The files contain information from CDRH's device experience reports on devices which may have malfunctioned or caused a death or serious injury. The files contain reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 ‐ 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports. U.S. Food and Drug Administration, Center for Devices and Radiological Health (CDRH), Manufacturer and User Facility Device Experience Database, MAUDE, (http://www.fda.gov/cdrh/ maude.html). MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. Expression MR400 Instructions for Use Guidelines and References E‐5 E‐6 Guidelines and References Expression MR400 Instructions for Use Notes Notes Notes Notes Notes Notes Notes Notes
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